UNITED STATES OF AMERICA
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
JOINT MEETING OF THE
DENTAL PRODUCTS AND
EAR, NOSE AND THROAT DEVICES PANELS
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OCTOBER 6, 2004
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The panels met at 8:30 a.m. at the Hilton
Washington, D.C./North, 620 Perry Parkway,
Gaithersburg, Maryland, DR. A. JULIANNA GULYA, Chair
of the ENT Panel, presiding.
A. JULIANNA GULYA, M.D., Chair
KAREN H. CALHOUN, M.D., FACS, Consultant
R. MICHAEL CROMPTON, J.D., M.P.H., RAC, Industry
HERMAN A. JENKINS, M.D., Voting Member
ERIC A. MAIR, M.D., Consultant
LISA A. ORLOFF, M.D., Consultant
CAROLYN R. STERN, M.D., Consumer Representative
DAVID J. TERRIS, M.D., Consultant
GAYLE E. WOODSON, M.D., Consultant
SARA M. THORNTON, Executive Secretary
DENTAL PRODUCTS PANEL:
JON B. SUZUKI, D.D.S., Ph.D., M.B.A., Chair
B. GAIL DEMKO, D.M.D., PC, Consultant
ELIZABETH S. HOWE, Consumer Representative
KASEY K. LI, D.D.S., M.D., Consultant
DANIEL R. SCHECHTER, ESQ., Industry
DOMENICK T. ZERO, D.D.S., M.S, Voting Member
JOHN R. ZUNIGA, Ph.D., D.M.D., Voting Member
A. RALPH ROSENTHAL, M.D., Director, Division of
Ophthalmic and ENT Devices
M. SUSAN RUNNER, D.D.S., M.A., Chief, Dental
Devices Branch, Captain, USPHS
ERIC A. MANN, M.D., Ph.D., Chief, ENT Devices
Branch, Captain, USPHS
HEATHER S. ROSENCRANS, Director, Premarket
KEVIN P. MULRY, D.D.S., M.P.H., Dental Officer ‑
Dental Devices Branch
AGENDA ITEM PAGE
Call to Order 4
A. Julianna Gulya, M.D., Chair
Introductory Remarks 7
Sara M. Thornton ‑ Executive Secretary
Conflict of Interest Statement 10
Sara M. Thornton ‑ Executive Secretary
Branch Updates 12
Captain Eric A. Mann, M.D., Ph.D. ‑
FDA Presentation 19
Heather S. Rosecrans ‑ Program 19
Captain Eric A. Mann, M.D., Ph.D. ‑ 25
Kevin P. Mulry, D.D.S., M.P.H. ‑ Dental 45
Open Public Hearing Session 64
Panel Presentations 97
David J. Terris, M.D. 97
B. Gail Demko, D.M.D. 115
Panel Deliberations 145
Second Open Public Hearing Session 324
CALL TO ORDER
CHAIRPERSON GULYA: I now call this joint
meeting of the Food and Drug Administration Center for
Devices and Radiological Health joint meeting of the
Ear, Nose, and Throat Devices Panel and Dental
Products Panel into session.
I see we have a number of individuals who
are interested in today's meeting regarding the
prescription versus the over‑the‑counter use devices
intended to treat snoring and/or obstructive sleep
apnea. And I am very appreciative of that.
I think we will quickly go around the
table and perform introductions here, starting on my
DR. ROSENTHAL: Ralph Rosenthal. I'm the
Director of the Division of Ophthalmic and ENT
DR. RUNNER: I'm Susan Runner. I'm the
Branch Chief of Dental Devices and the Deputy Director
of the Division of Anesthesia, General Hospital and
Infection Control Devices.
DR. DEMKO: Gail Demko. I'm a consultant
to the Dental Products Panel.
DR. CALHOUN: Karen Calhoun. I'm an
otolaryngologist at the University of Missouri.
DR. TERRIS: Dave Terris. I'm a
consultant as well. I'm at the Medical College of
DR. WOODSON: Gayle Woodson,
otolaryngologist, consultant, Southern Illinois
University in Springfield, Illinois.
DR. ORLOFF: Lisa Orloff, consultant to
the ENT Devices Panel from University of California,
DR. MAIR: Eric Mair, otolaryngologist
from Wilford Hall in San Antonio, Texas.
MEMBER ZUNIGA: I'm John Zuniga. I'm a
member on the Dental Panel from UNC, North Carolina.
CHAIRPERSON GULYA: Julie Gulya. I'm at
the National Institute on Deafness and Other
EXECUTIVE SECRETARY S. THORNTON: Sara
Thornton, Executive Secretary for the Ear, Nose, and
Throat Devices Panel.
MEMBER SUZUKI: Jon Suzuki, Dental
Products Panel, Associate Dean at Temple University.
MEMBER JENKINS: Herman Jenkins,
Otolaryngology, University of Colorado.
DR. LI: Kasey Li, consultant from
Stanford Sleep Disorders Clinic.
MEMBER ZERO: Domenick Zero, Dental
Products Panel, Associate Dean for Research, Indiana
University School of Dentistry.
DR. STERN: Carolyn Stern, family
physician, consumer rep for the ENT Panel.
MS. HOWE: Betsy Howe, consumer rep for
the Dental Panel.
MR. SCHECHTER: Dan Schechter, industry
representative for the Dental Panel.
MR. CROMPTON: And Mike Crompton, industry
rep for the Ear, Nose, and Throat Devices Panel.
CHAIRPERSON GULYA: Okay. Thank you very
much. Without further ado, I will turn it over now to
Ms. Sally Thornton, our Executive Secretary.
EXECUTIVE SECRETARY S. THORNTON: Good
morning. On behalf of FDA, I would like to welcome
you to the very first joint meeting of the Dental
Products and Ear, Nose, and Throat Devices Panels in
the Twenty‑First Century.
EXECUTIVE SECRETARY S. THORNTON: Before
we proceed with today's agenda, I have a few short
announcements to make. I would like to remind
everyone here to sign in on the attendance sheet in
the registration area just outside the meeting room.
All public handouts for today's meeting are available
at the registration table.
Messages for panel members and FDA
participants, information or special needs should be
directed through Ms. AnnMarie Williams, who is
available in the registration area. The telephone
number for calls to the meeting area is (301)
In consideration of the panel and the
agency, we ask that those of you with cell phones and
pagers either turn them off or put them on vibration
mode while in this room and make your calls outside
the meeting area. We strive to make this a cell
Lastly, will all meeting participants
please speak into the microphone and give your name
clearly so that the transcriber will have an accurate
recording of your comments.
At this time, I would like to extend a
special welcome and introduce again to the public and
the panel and the FDA staff new panel consultants who
are with us at the table for the first time: Dr. Gail
Demko from the Dental Panel, Dr. Kasey Li from the
Dental Panel, Dr. Eric Mair from the ENT Panel, Dr.
Lisa Orloff from the ENT Panel, Dr. David Terris from
the ENT Panel, and Dr. Carolyn Stern, the consumer rep
for the ENT Panel. Those folks are joining us today
for the first time.
There are two other announcements of note
that I would like to make at this time. The first is
to recognize that ENT Panel voting members, Dr.
Julianna Gulya on my left here, who is Chair; Dr.
Herman Jenkins; and also Dr. Howard Francis, who is
not with us today, and ENT industry rep, Mr. Michael
Crompton, will serve on the ENT Panel today for the
last time in that capacity. Their term expires on
October 31st of this year.
We want them to know that their dedication
to the work of the panel has been much appreciated.
And we are very grateful for their willingness to
serve. FDA owes you a resounding thank you for all
you have given us. And we will be sending you a
special remembrance for your service. Please join me
in thanking them.
EXECUTIVE SECRETARY S. THORNTON: The
second is to announce the voting members who will
begin their terms on 11‑1‑2004. They are Drs. Eric
Mair and Lisa Orloff, whom you have just met, and Dr.
Kathleen Sie, who is with the University of Washington
in the Children's Hospital Medical Center in Seattle,
Washington. Dr. Mair will be the new panel chair.
CONFLICT OF INTEREST STATEMENT
EXECUTIVE SECRETARY S. THORNTON: Now I
would like to proceed with the reading of the conflict
of interest statement for this meeting. "The
following announcement addresses conflict of interest
issues associated with this meeting and is made part
of the record to preclude even the appearance of an
impropriety. To determine if any conflict existed,
the agency reviewed the submitted agenda for this
meeting and all financial interests reported by the
"The conflict of interest statutes
prohibit special government employees from
participating in matters that could affect their or
their employers' financial interests. To determine if
any conflict existed, the agency reviewed the
submitted agenda for this meeting and all financial
interests reported by the committee participants.
"The agency has no conflicts to report for
today's agenda. However, we would like to note for
the record that the agency took into consideration
certain matters regarding Drs. Gail Demko, Eric Mair,
and David Terris. They reported interests in firms at
issue but in matters not related to today's agenda.
The agency has determined, therefore, that they may
participate fully in all discussions.
"In the event that the discussions involve
any other products or firms not already on the agenda
for which an FDA participant has a financial interest,
the participants should excuse him or herself from
such involvement, and the exclusion will be noted for
"With respect to all other participants,
we ask in the interest of fairness that all persons
making statements or presentations disclose any
current or previous financial involvement with any
firm whose products they may wish to comment upon."
Thank you, Dr. Gulya.
CHAIRPERSON GULYA: Thank you very much,
While proceeding along on our agenda, we
will next hear from Dr. Eric Mann, who is the Chief of
the Ear, Nose, and Throat Devices Branch.
DR. MANN: Good morning, distinguished
panel members, FDA colleagues, and guests. The last
meeting of the Ear, Nose, and Throat Devices Panel
occurred in August of 2002. And we would like to take
this opportunity to give you a brief update on the
branch and some of its activities since that last
We have had a number of staffing changes
within the branch recently. Aside from myself as
Branch Chief, we have Ms.
Karen Baker as our nurse consultant. We have two
audiologist reviewers: Ms. Teri Cygnarowicz and Dr.
James Kane. Dr. Vasant Malshet is our branch
And we are very pleased and privileged to
have two new reviewers within our branch as of last
fall. Dr. Srinivas Nandkumar is an electrical
engineer with signal processing background. And Dr.
Antonio Pereira is a practicing otolaryngologist/head
and neck surgeon, who also serves as a part‑time
medical officer for our branch. And Dr. Pereira takes
over for Dr. Sid Jaffee, whom some of you may recall
has served our branch so well for the pst years. We
wish Dr. Jaffee well in his retirement.
We have had one original PMA approved
since the last panel meeting. The Karl Storz
autofluorescence system was approved in December of
2002 for the indication of use of white light in
autofluorescence bronchoscopy to identify and locate
abnormal bronchial tissue for biopsy and histological
The target patient populations for this
new device are patients with suspected bronchogenic
carcinoma, those previously diagnosed with lung
cancer, and those patients who demonstrate abnormal
sputum cytology, abnormal chest X‑ray, CT scan, or
other similar technology.
Here is a photograph of the entire
autofluorescence system. On the left, you can see
consists of a bronchoscope, a light source with a
variety of filters, a camera, and a video output
display monitor on the top. On the upper right‑hand
photograph, you see a photograph of the lower airways
with white light used during a traditional white light
Below that, you see the same area
illuminated with the autofluorescence mode of the
system. And you can see several areas of reduced
autofluorescence, which indicate possible areas of
abnormality and may require biopsy.
We have had quite a number of PMA
supplements submitted since the last panel meeting.
And I would like to share a few of the more important
ones related to cochlear implants.
Cochlear Americas received approval for a
design change to their electrode for their Nucleus 24
contour system. The new electrode is a longer,
specialized electrode tip, which is shown here. The
new electrode is called the soft‑tip electrode. It
features an advance off stylet insertion technique.
I think you can see the stylet here on the left side
of the figure. The new electrode tip is advanced off
of that stylet into the cochlea with the aim of having
a less dramatic insertion into the cochlea and
ensuring a more consistent perimodiolar placement of
the new electrode.
We also approved an advance off stylet
insertion tool in October of 2003. It's shown here on
the left. This insertion tool is to be used with the
new electrode and permits the surgeon to use a single
hand insertion technique during the implant surgery.
MED‑EL Corporation received approval in
August of 2003 for a medium active electrode array.
This new design features contact spacing, which has
been optimized for special difficult cases of cochlear
implantation, specifically those patients who have
cochlear ossification or congenital malformations of
Like the standard array, it consists of 12
pairs of electrode contacts, but they are compressed
together at the distal end of the electrode, as shown
in this figure here, which facilitates a higher
likelihood of complete insertion in these more
The company also received approval for an
MRI indication. The device can be used with MRI at
0.2 tesla field strength. However, proper positioning
of the patient within the magnetic field is necessary.
And the imaging facility is directed to contact MED‑EL
prior to the MRI study to ensure that proper
procedures are followed during the MRI.
Finally, the third manufacturer of
implants within the U.S., the Advanced Bionics
Corporation, received approval for a major repackaging
design change to their implantable cochlear
stimulator, shown here on the left. The new
stimulator is called the HiResolution Bionic Ear
System, or HIRES 90K for short. It features a
silicon‑embedded titanium case. This is a smaller
case compared to the previous generation of the
CLARION device, which was made out of ceramic.
The agency also granted approved for a new
HiFocus Helix precurved electrode, which is shown here
on the lower left. The electrode achieves this
precurved configuration, perimodiolar configuration,
within the cochlea after removal of an insertion
Finally, the company received FDA approval
for MRI compatibility with their device at field
strengths of 0.3 and 1.5 tesla. Prior to the MRI
study, the magnet within the implanted device has to
be removed. The MRI study is conducted. And then the
magnet is replaced with minor surgical procedures.
As you may be aware, Advanced Bionics
recently issued a worldwide voluntary recall of all
unimplanted clarion and high‑resolution bionic ear
systems. The company undertook this action in
response to the finding of moisture within the implant
case of explanted devices, devices that had been
explanted for either medical reasons or for device
failures. In some cases, they were able to link the
moisture within the implanted case with the actual
device malfunction and failure.
The company is currently taking steps to
address this by looking at their manufacturing
processes, but in the meantime, FDA has worked with
the company to draft notification letters for doctors,
patients, and hearing health care professionals.
These letters went out last week.
Of note, FDA is not recommending removal
or replacement of normally functioning implanted
devices. And the overall failure rate for these
devices to date has been relatively low.
Finally, I am very pleased to announce
that within the next week we will be making available
a CDRH cochlear implant Web site, with the Web link
The target audience for this cochlear
implant Web site is current and prospective cochlear
implant users, their parents, families, educators, and
health care providers who may be involved with these
The content of the Web site includes
information regarding cochlear implant design and
function, including some very nice animated graphics,
gives details about the cochlear implant surgery, and
addresses some frequently asked questions. A very
nice feature also is that it provides easy links to
FDA regulatory approvals for these devices. So we
think this will be a significant contribution to the
resources out there available to the public on
This concludes the branch update.
CHAIRPERSON GULYA: Thank you very much,
We do have a very tight morning schedule,
but I feel it incumbent upon us to at least be given
the opportunity to have some burning questions
answered. Are there any such burning questions for
Dr. Mann before we proceed to Ms. Rosecrans?
CHAIRPERSON GULYA: Okay. Great. Ms.
Heather Rosecrans, please? I think you were next on
our schedule for a presentation. Most of you should
have a copy of her slides as a handout.
MS. ROSECRANS: Thank you very much.
I'm here this morning to just briefly
discuss with you a subject that I am sure you are
familiar with, which is prescription and
over‑the‑counter use. I just want to give you a few
examples and briefly go over the regulations we use to
distinguish these two was of regulating and labeling
Basically it surrounds adequate directions
for use, whether or not there can be adequate
directions for use written for a lay person.
Generally we're looking at the sixth or seventh grade
level, considering how to write that labeling for a
lay person, or if adequate directions for use cannot
be written for a lay person, it would be considered a
Our regulations, or actually our labeling
regulations, are found in our Code of Federal
Regulations in chapter 801. They describe the
over‑the‑counter devices, again those for which
directions for use can be written for a lay person, as
well as prescription devices, which are exempt
technically by our regulations, exempt from adequate
directions for use, meaning for a lay person, but
obviously they have directions for use for the
We also have what is considered under
prescription devices prescription home use. So that
would be a prescription device that you send home with
the patient to use. for example, prothrombin time
tests used in cardiovascular disease are given by the
physician to the patient. They pick them up at the
pharmacy and then use them in their home and report
back to the physician.
If a firm had a prescription device and
they wanted to market it over the counter, that would
require a new application before the agency.
And, lastly, I wanted to mention that we
do have many devices that are both prescription and
over‑the‑counter. Someone can actually come in to use
with a submission for a device that is both
prescription and over‑the‑counter. The distinction
would be how they are going to label the product. And
obviously they would be packaging it differently as
well, but it could be that's the very same device. A
good example of this would be pregnancy test kits.
Okay. So obviously I'm sure you're very
aware the over‑the‑counter devices are available for
purchase directly by any lay person or consumer. And
they involve self‑diagnosis, et cetera. Again, they
require adequate directions for use for that lay
A prescription device ‑‑ and this is the
definition from our regulation ‑‑ is a device which
because of any potentiality for harmful effect or the
method of its use or the collateral measures necessary
to its use, it's not safe except under the supervision
of a practitioner licensed by law to direct the use of
such a device and, hence, for which adequate
directions for use cannot be prepared, again meaning
for a lay person. As I just said, they would be
exempt for a lay person. And, again, they include
those home use devices. That's considered
The labeling that we require in our
regulations would be "Caution: Federal law restricts
the device to sale by or on the order of a." And
that's to be filled in with any one licensed by the
state to use that prescription‑type product. Okay?
And, again, the states enforce these
prescriptions, even though the federal law requires
the statements. Normally we allow the states to go
ahead and enforce them because every state, as I'm
sure you are very well‑aware, is different in what
they allow. And also the method of its application
for use has to be addressed.
I just wanted to, lastly, just go over a
couple of examples for you that you may be familiar
with. Recently, I think in September, we just cleared
under the 510(k) process, actually, a device that went
from prescription to over‑the‑counter.
And there was a public panel meeting in
July. Those are the automatic external
defibrillators. We just cleared our first
over‑the‑counter one. Previously they were
prescription and then prescription home‑use. And,
again, now we have cleared our first over‑the‑counter
I should also let you know that in the
510(k) program, which I know you have had training on,
if a device has been cleared for prescription use and
they want to market it as a prescription home use
device and they make no other changes to the product,
that would just involve they would be adding labeling
for the home use environment. That does not require
a submission to the agency if it's accepted medical
practice in the United States. If in the PMA area it
went from prescription to prescription home use, that
does require a PMA supplement.
A couple of other examples of things that
we have in the near recent past cleared as
over‑the‑counter would be the cryotherapy systems for
warts have recently gone over‑the‑counter through the
510(k) process. As I said, pregnancy test kids; the
prothrombin test again would be prescription home use.
Ovulation predictor test several years back went
over‑the‑counter through the 510(k) process.
And examples such as over‑the‑counter
strep tests and over‑the‑counter gonorrhea tests have
actually not been allowed to go to market at this
time. It was determined the impact on public health
was too great and had significant safety and
effectiveness concerns. So, therefore, to date we
have not allowed those over the counter. But, as you
are aware, I am sure, we have allowed the AIDS test to
go over the counter. And the risk‑benefit decision
for that was met before a panel.
So that's what I have for you today.
CHAIRPERSON GULYA: Thank you, Ms.
MS. ROSECRANS: Thank you.
CHAIRPERSON GULYA: Are there any
questions at all from the panel?
CHAIRPERSON GULYA: Okay. Thank you very
much. Next we will turn to Dr. Mann.
DR. MANN: Again, good morning and welcome
to our distinguished panel members. This certainly is
a rare opportunity for us here at FDA to have access
to such a wealth of clinical experience from both the
Dental and the ENT Advisory Panels. We very much
appreciate your willingness to attend and prepare for
this meeting and to share your knowledge with us as we
consider important regulatory questions related to
over‑the‑counter use of medical devices for the
treatment of snoring and obstructive sleep apnea.
I would like to open this morning's
session by giving you a brief history of the subset of
ear, nose, and throat devices which have been proposed
and in some cases cleared for over‑the‑counter
treatment of snoring and obstructive sleep apnea.
The purpose of this slide is to basically
demonstrate that although we have had many devices
cleared in the past for indications related to snoring
or obstructive sleep apnea, we don't have a single
division or branch within the agency that deals with
that indication, snoring or obstructive sleep apnea.
In fact, we have at least four branches
within our office that have been involved in a review
of these devices. The Dental Devices Branch obviously
would review things like oral appliances, jaw
positioning devices, and also an assortment of other
devices, such as palatal implants and the Repose
tongue base suture system.
Our branch, the Ear, Nose, and Throat
Devices Branch, has reviewed nasal dilators, cervical
pillows, and a category that I will define a little
bit later called mandibular support devices.
The Anesthesia and Respiratory Devices
Branch has regulated the wide variety of CPAP devices
currently out on the market, which are obviously a
mainstay of OSA treatment.
And the General Surgery Devices Branch has
regulated devices with more generic surgical
applications, such as the lasers and the devices using
Now, despite the fact that these devices
are all in different branches, I would emphasize that
there is extensive formal and informal consultation
that goes on between branches if there are clinical or
technical issues that arise. And I would also
emphasize for the purpose of the panel discussion
today, we are not addressing CPAP devices and the
surgical devices, which obviously would not be good
candidates for an over‑the‑counter indication.
So, with that, I will be focusing my
presentation this morning on the three categories up
here on the left, which have been proposed for
over‑the‑counter use. So I will begin with the nasal
dilator, which is defined within the Code of Federal
Regulations as a device intended to provide temporary
relief from transient causes of breathing difficulties
resulting from structural abnormalities and/or
transient causes of nasal congestion associated with
reduced nasal air flow. The device decreases airway
resistance and increases nasal air flow.
These devices were the subject of an ENT
Devices Panel classification meeting back in October
of 1990. At that time, it was determined that they
would be regulated as Class I devices. I would point
out that since that time, all of the indications that
have been cleared pretty much have been
over‑the‑counter indications. And the early
indications mainly focused on things like reduction in
nasal airway resistance and increase in nasal air
This slide illustrates that the regulation
also kind of breaks down nasal dilators into internal
and external variations. The external variation,
shown on the left here, basically consists of a skin
adhesive coupled to a spring‑like material. It is
placed over the dorsum of the nose and pulls the
lateral walls of the nose out laterally to expand the
nasal airway over the region of the nasal valve. Here
is an example of one, the Breathe Right Nasal Strip,
which most of us are familiar with.
We also have a variety of internal nasal
dilators, a good example being the Breathe With Eez
nasal dilator shown here. It is a stainless steel
wire frame that is inserted into the nostril and
basically supports and expands the distal nasal
We also have on the market a device called
Breathe EZ, which again goes into the nostril but in
this time it's actually straddling the columella and
compressing the septum bilaterally.
Finally, I would call your attention to
the Nozovent device here at the bottom, which consists
of a spring‑like center strut and two flanges on
either side. This is inserted into the nostrils and
presses out laterally on the lateral nasal airway to
expand the distal nasal airway as well.
As I mentioned on the previous slide, the
indications for these devices early on basically
centered on things like reduction in nasal airway
resistance and increases in nasal air flow. But the
Nozovent device down here at the bottom was actually
the first device that came in seeking an
over‑the‑counter snoring claim.
This was back in the early 1990s. The
company recognized that the over‑the‑counter snoring
indication consisted a new indication for use, and
they did submit a 510(k). Within that 510(k), they
presented clinical data to support the safety and
effectiveness of the Nozovent device for snoring.
While I can't disclose all of the contents
of that submission, some of the data used to support
the indication have been subsequently published, as
shown here and basically showed a reduction in
subjective snoring skills and so forth.
Based on the clinical data provided, the
labeling submitted, and other information within the
510(k), it was, in fact, cleared in August of 1991 for
an over‑the‑counter snoring indication. It obviously
opened up the doorway for other nasal dilators to come
in seeking a similar indication.
So following the Nozovent clearance, the
FDA policy for nasal dilators seeking a snoring
over‑the‑counter indication has been as follows.
Assuming that the device has the same indications for
use or very similar technological characteristics to
the nose event or another suitable predicate device,
no clinical data has been required to support a
snoring OTC indication. And typically what has been
submitted are things like design specifications,
material specifications, and some bench‑top testing as
appropriate to demonstrate substantial equivalence to
that predicate device.
However, if there is new technology or new
indications for use, they would have to come in with
a 510(k) with clinical data. An example of that would
be the Breathe Right Nasal Strip. When they came in
seeking an OTC snoring claim, that was obviously
different technology from the internal nasal dilator
with the Nozovent device. So they did submit clinical
data to support clearance of their snoring claim for
Now, one of the things that happened in
the late 1990s was the passage of the Food and Drug
Modernization Act. And under the provisions of this
act, the vast majority of Class I devices became
exempt from pre‑market or 510(k) notification. This,
indeed, was the case for nasal dilators as well
effective April of 1999. However, I would point out
that this exemption is subject to limitations. And
any device which has new technological characteristics
or new intended use would still be required to come
into the agency with a 510(k) and clinical data to
support the indication. I would point out that there
have been no obstructive sleep apnea indications
cleared for these devices to date.
FDA has reviewed the labeling for these
products in the past for snoring indications and in
general has ensured that the adequate labeling
precautions and warnings are included. The exact
wording of these precautions and warnings has varied
somewhat, but in general they all instruct the patient
to seek medical attention for any abnormal breathing
patterns during sleep, pauses, and breathing, daytime
sleepiness, difficulty breathing, gasping, choking for
air at night, and so forth, things that would indicate
potential for diagnosis of sleep disorder breathing.
In addition, the labeling has also
included instructions to cease use if there is
evidence of skin or mucosal irritation depending on
whether it's an internal or external nasal dilator.
The consumer is instructed not to exceed the
recommended duration of use for the product. And the
product has been labeled not for use in individuals
under the age of five.
I did a quick search of our computerized
database of previously cleared nasal dilators that
have been cleared for this snoring claim and came up
with a quick list of about seven devices that we have
within our database, but I would emphasize that since
the FDMA was passed, many of the newer devices have
not had to come in with a 510(k). So this is clearly
not a complete list of nasal dilators out there on the
market for snoring.
So that covers the nasal dilators. I'd
like to next move to cervical pillows, which have also
been regulated by our branch for these indications.
Unlike nasal dilators, we have no classification
regulation for cervical pillows for the indication of
snoring or obstructive sleep apnea, but the agency has
determined that these devices when they're marketed
for either a snoring or an OSA indication do fall
within the definition of a medical device because
they're intended to affect the structure or the
function of the body.
In the early 1990s, we had quite a few
510(k)'s that had come in seeking a snoring
indication. Based on the large potential number of
510(k)'s that would be coming in, the limited
resources of the agency, and the relatively minimal
risks associated with the direct use of a pillow, it
was decided that FDA would exercise regulatory
enforcement discretion for pillows being marketed for
the snoring indication. I would emphasize this is for
the snoring indication only, not for any other medical
conditions, like obstructive sleep apnea.
So under this regulatory enforcement
discretion policy, no 510(k) pre‑market notification
has been required for pillows just seeking the snoring
OTC indication. There's been no enforcement of
section 807 of the regulations regarding registration
and listing requirements. These devices still are
subject to adulteration and misbranding provisions of
the Food, Drug, and Cosmetic Act. And FDA has always
reserved the right to change this policy if determined
to be necessary.
Now, this exercise of regulatory
discretion has always been contingent upon the sponsor
agreeing to some labeling conditions. As I stated
before, there can be no other medical claims for the
In addition, we have insisted that they
include these warnings and contraindications,
essentially the warnings, instruct the patient to seek
consultation with the physician if they have signs or
symptoms of obstructive sleep apnea, such as excessive
daytime sleepiness or pauses in breathing similar to
the labeling for the nasal dilators.
There were some contraindications that
were required in terms of contraindicating patients
with heart disease being substantially overweight.
And the product had to be labeled for not for use by
infants or children and to discontinue use if pain or
So this was the policy that was developed
in the early 1990s. And since that time, many
manufacturers have agreed to abide by these conditions
and have been marketing their pillows for snoring OTC
conditions without submission of 510(k)'s to the
The first cervical pillow that came to the
agency seeking an OSA indication was the
PillowPositive II Cervical Pillow. This was back in
1999. The sponsor was Life Sleep Systems. They had
been one of the companies that had been marketing
their pillow for the snoring indication under the
terms of the regulatory discretion that I just
described. But they did recognize that the OSA would
be a new indication for use and came into the agency
with the 510(k) seeking a claim for snoring and mild
obstructive sleep apnea.
To support this indication, they submitted
clinical data. Again, I can't go into detail about
everything within the content of that 510(k), but some
of that information has been published as well. I can
include the references here. And I think one of these
references is actually in the panel briefing packet,
basically demonstrating reduction of respiratory
disturbance index with use of the pillow compared to
Based on the clinical evidence supplied
within the 510(k), review of the labeling and so
forth, this was, in fact, cleared in June of 1999 for
both a snoring and mild obstructive sleep apnea
indication. This clearance was for prescription use
There were several instructions regarding
measurements that had to be taken of the patient,
fitting of the pillow to the individual patient by the
health care provider. So it was labeled as a
prescription use only, and the sponsor did not request
over‑the‑counter indication for this pillow.
The labelling for the patient did, in
fact, contain the same warnings and contraindications
that we have prescribed previously for snoring pillows
and nasal dilators.
Now, since that time, we have had two
cervical pillows that have also been cleared for a
mild obstructive sleep apnea indication in addition to
snoring. The first of these was the Popitz Pillow,
which came in in 2002. It was similar to the previous
pillow in terms of the technology of cervical
positioning to achieve increased patency and stability
of the airway. This pillow essentially places the
patient or the consumer in the snit position with neck
flexed, head extended to stabilize and open the
The 510(k) was, in fact, cleared for the
snoring and mild obstructive sleep apnea indication in
October of 2002. There were numerous factors that
went into that decision‑making process. First of all,
the sponsor had submitted clinical data supporting the
effectiveness of cervical positioning and mild
obstructive sleep apnea, similar to the evidence
presented in the previous slide.
There was a recognition that there may be
some fuzziness or crossover between patients out there
with primary snoring, snoring only in mild obstructive
sleep apnea. We know that from night to night, there
is a significant variation in patient symptoms and the
results of studies from various centers using various
criteria. So the distinction between snoring and mild
obstructive sleep apnea is not always that clear‑cut
on individual patients.
Third, we had a long history of safe use
for snoring pillows over the counter, as I will get to
in a couple of minutes, but basically no significant
adverse events have been reported to FDA for snoring
pillows for the past ten‑plus years.
Finally, it was felt that the sponsor had
submitted adequate directions for use for an OTC
indication. In particular, this pillow did not
involve any sort of fitting or specialized
measurements that had to be taken like the previous
pillow. And it did include all of the warnings,
contraindications, and so forth, in terms of
instructions to seek medical attention for signs and
symptoms of obstructive sleep apnea.
So kind of based on all of these factors,
it was felt that adequate directions for use had been
supplied in submission. And it was cleared in October
of 2002. Since that time, we have received one
additional 510(k) for the indication of mild
obstructive sleep apnea and snoring. It's the Soma
Pillow. It was cleared in April of this year based on
clinical data with the pillows supplied by the sponsor
as well as consideration of the other factors
mentioned for the Popitz Pillow.
So, in summary, we have basically three
pillows cleared for mild obstructive sleep apnea,
snoring, one of which is a prescription device and
these two of which are over‑the‑counter.
I would like to finally move on to the
category that we are terming "mandibular support
devices." These devices are essentially those that
support the mandible in the closed position. I
downloaded some pictures of CPAP chin straps from the
Web. This is basically what we're talking about when
we speak of mandibular support devices. They're
basically supporting the mandible in the closed
Like snoring pillows or cervical pillows,
we have no classification regulation for mandibular
support devices. In fact, we have received no
510(k)'s for these devices to date. The reason why I
am mentioning them during this meeting is that we have
received numerous informal queries from industry
regarding the types of studies and the types of data
that would be required to support safety and
effectiveness of these devices for either snoring
and/or obstructive sleep apnea.
In general, the literature that has been
cited in support of these types of devices are those
such as I have shown here, which basically show that
the mouth open position is associated with increased
collapsibility of the upper airway and a narrowing of
the airway, so the presumption being closure of the
mouth with one of these support devices would enhance
patency and stability of the airway. So I raise this
as a possibility of things that we might be seeing in
Finally, I would just like to give you a
brief overview of our post‑market adverse event
experience with these three categories of devices. We
did a search of our computerized database, the MAUDE
database, which captures both voluntary and mandatory
adverse event reports dating back to the early '90s.
With respect to nasal dilators, we have had four
adverse event reports.
Two were related to skin irritation with
the use of an external nasal dilator, nasal strip.
One reported eye irritation related to use of a nasal
strip, although it was unclear how the eye irritation
was tied to use of the device.
Finally, we have one report of an internal
nasal dilator that was actually displaced into the
posterior nasal cavity. We have received no adverse
event reports for cervical pillows for the snoring and
obstructive sleep apnea indication to date.
Finally, even though we have had no
510(k)'s for the mandibular support devices, we do
have one event reported in the database of transient
airway obstruction in a patient using an illegally
marketed device. They basically woke up gasping for
air, pulled off the strap. Fortunately, there was no
significant sequelae related to that, but it was
reported in our database.
In general, the ten‑plus‑year experience
with these devices has demonstrated that there have
been relatively few adverse events reported. And
those reported have, by and large, been minor in
That being said, I think it's given that
there is a significant under‑reporting of minor
adverse events. Dr. Mair has published a very nice
study, prospective study, of experience in a patient
population with these over‑the‑counter devices. As I
understand it, a number of those patients experienced
some minor adverse events. So I'm hoping this
afternoon perhaps he can share the knowledge that he
gained from conducting that study with us.
So that concludes my portion of the
presentation. If there are no questions, I will turn
things over to Dr. Kevin Mulry, who will be discussing
the dental devices and their history.
CHAIRPERSON GULYA: I think in view of the
time, we will proceed with Dr. Mulry's presentation.
Then we can hopefully interweave questions after we
have our open public hearing session before we dive
into our deliberations. Thank you very much, Eric.
DR. MULRY: Good morning. I would also
like to add my welcome to the panel and thank you for
taking the time today to come and join us in this very
important discussion of devices for the treatment of
snoring and/or obstructive sleep apnea.
EXECUTIVE SECRETARY S. THORNTON: Kevin,
you can move that up to your mouth.
DR. MULRY: Thank you.
EXECUTIVE SECRETARY S. THORNTON: But we
need you to speak closely into it.
DR. MULRY: Okay. Dr. Mann has presented
the ENT Branch's perspective on the regulation of
these devices. I am now going to present the Dental
Branch's perspective on the regulation of these
So the scope of the dental devices that
we're going to discuss today includes intraoral
devices only. They are devices that are fitted over
the teeth and tongue and are removable. I want to
reiterate that the discussion to date does not include
implantable devices, surgical devices, CPAP, or
The regulatory history for the dental
devices is that the panel met, the Dental Products
Advisory Committee, met in November 1997 to classify
intraoral devices for the treatment of snoring and
obstructive sleep apnea.
The panel recommended that these devices
be classified into Class II with special controls in
order to provide reasonable assurance of the safety
and effectiveness of these devices. This means that
sponsors need to submit a 510(k) or pre‑market
notification to the agency for market clearance. And
a special Class II special controls guidance document
was published in 2002 as the special control for this
Class II regulation.
In some sponsors, one of the impetuses for
the meeting today is that sponsors have requested that
these devices be made over the counter. That is the
reason we are asking for your input today as to what
data sponsors should submit to provide reasonable
assurance of safety and effectiveness for
over‑the‑counter use for dental devices.
Intraoral devices are cited in the Code of
Federal Regulations under 21 CFR 872.5570. The
regulation states that intraoral devices for snoring
and intraoral devices for snoring and obstructive
sleep apnea are devices that are worn during sleep to
reduce the incidence of snoring and to treat
obstructive sleep apnea. The devices are designed to
increase the patency of the airway and to decrease air
turbulence and airway obstruction.
The agency published a Class II special
controls guidance document, which I believe was
provided in your panel packs. The document is
intended to inform manufacturers regarding the data
needed in a 510(k) submission. In developing this
guidance document, the agency has considered it the
least burdensome approach to resolving the statutory
The guidance document includes the risks
to health generally associated with the use of these
devices and recommends measures to mitigate the
identified risks. The guidance document also includes
recommendation for biocompatibility testing for the
devices, clinical testing that may be needed based
upon the individual devices, and labeling.
So what are the types of dental device
designs for intraoral devices? The classification
includes three basic designs: the tongue retaining
devices, the mandibular repositioning devices, and the
palatal lifting devices.
The tongue retaining device are intended
to increase pharyngeal space to improve the patient's
ability to exchange air by supporting the tongue in an
The mandibular repositioning devices are
designed to move the mandible into a more anterior
position and provide support for the jaw at rest.
This is intended to create a larger airway space,
thereby decreasing airway turbulence, tissue
vibration, and airway obstruction.
The palatal lifting devices are designed
to lift the soft palate, thereby increasing airway
patency. The device is designed to support the soft
palate, thereby decreasing tissue vibration and
decreasing the intensity of the snoring.
Intraoral devices for snoring and
obstructive sleep apnea have been cleared for the
treatment of snoring and the treatment of snoring
and/or mild to moderate obstructive sleep apnea but
not severe sleep apnea, and they have been
prescription use only. All dental devices have been
prescription use only.
This slide demonstrates some examples of
the types of device designs. The one on the left is
a tongue retaining device. It contains a bulb into
which the tongue is placed. And the tongue is held in
place by suction.
The mandibular aspect here is fitted over
the teeth to stabilize the device. And the device is
held in this anterior position through the pressure or
the resting of this aspect of the device depending on
the design against either the lips or the jaw. And
also the mandibular aspect since it is fitted to the
teeth also prevents the device from moving in a
The device on the right is a mandibular
repositioning device. It depicts the mandible in an
anterior position to centric occlusion or your normal
You can see here that in the anterior
area, there is an open space for oral breathing. That
is one of the things that we have required in all of
the submissions for intraoral devices, that there be
a mechanism for oral breathing since these devices can
be somewhat obstructive due to the nature of the
devices. And also we have concerns about those
patients who might have nasal congestion.
I would also like to point out the
mechanism for advancement on this type of device.
It's a keyed type of mechanism, which can unless the
device can be advanced either by the doctor or the
patient and it's a very gradual type of advancement
and may be able to advance due to 20 to 40 different
types of physicians.
I would like to contrast that with the
boil and bite mandibular repositioning devices that we
are seeing today. These tend to be a thermoplastic
material with slotted groves in the anterior of the
mandible aspect or the mandibular tray. There's
usually a pin or a stylus attached to the maxillary or
upper tray that fits into the slot of the lower tray.
This then has preset slots or preset advancement
settings. And there are usually two or three types of
settings on these types of devices.
Then on the right is the palatal lifting
device, which has a button, which is gradually
adjusted in a posterior direction back to the soft
palate towards the uvula. This is done in a very
gradual fashion because patients need to adjust their
gag reflex to the presence of this button as it can be
for many patients a difficult adjustment based upon
the natural gas reflex. The button is intended to
support the soft palate and, therefore, reduce the
vibration of the soft palate and reduce the intensity
Also, I want to go back just for a second
and say that the amount of advancement that we usually
see with these types of mandibular repositioning
devices has a wide range. It is usually about 50 to
75 percent of the maximum protrusive position. The
slotted mechanism is preset, and the advancements are
usually approximately 4 to 5 millimeters for the
treatment of snoring and approximately 8 to 10
millimeters for the treatment of obstructive sleep
So what are the trends the Dental Devices
Branch has seen in the few years with these devices?
The majority of the early designs for the mandibular
repositioning devices require that a dentist take an
individual impression or a custom impression of each
individual patient. They contain a lot of orthodontic
hardware, hinges, wires, et cetera, and also that they
had self‑adjusting advancement mechanisms that could
be adjusted by either the doctor or the patient.
The newer devices that we are seeing ‑‑
and there has been an increased interest in these ‑‑
are the boil and bite types of devices. These devices
vary in design but tend to have in common that they
have a thermoplastic material, which is heated and
then placed in the patient's mouth. And they have
preset advancement mechanisms.
This is important in that we will ask you,
the panel, today to consider the different types of
designs in the discussion of data that should be
submitted to the agency if you were to recommend that
over‑the‑counter devices be approved.
I just want to reinforce the concept of
the differences in the types of designs. Again, the
one on the left is one that is a generic type of
device. I will just use this, but there are many
different types of devices with a lot more wires and
a lot more complexity.
The issue here is that for this type of
device to be fabricated, it needs the dentist to take
an impression of the individual arches, both the upper
and lower arches; requires that it be poured in stone;
be sent off to a lab; the wires need to be fabricated
to fit the individual patient; and then they need to
add the advancement mechanism.
This is in contrast to the boil and bite
types of devices that are noted here that you can see
that there are slotted mechanisms on the mandible,
some type of pin or stylus on the maxillary or upper
aspect, which fits into the slots here.
So I just want to draw the contrast in the
types of devices that we have. The boil and bite
devices don't need to be sent to a laboratory, nor do
they need to be customized for each individual
The Class II special controls guidance
document made labeling recommendations that were based
upon the discussion of the Dental Products Panel
meeting in 1997. The guidance document lists
contraindications of central sleep apnea since these
devices, really, the intraoral devices, are intended
for obstructive sleep apnea, not central sleep apnea,
severe respiratory disorders, severe asthma, et
cetera, concerns for obstructing the patient who may
already be obstructed. Loose teeth or advanced
periodontal disease, these devices, especially the
mandibular advancement devices, put a lot of pressure
on, in particular, the lower anterior teeth and the
upper anterior teeth. And if a patient has loose
teeth or advanced periodontal disease, it may
compromise the dentition further.
We have contraindicated these devices in
patients under 18 years of age because we do not
believe that they should be used during the growth
phases of the jaw and the TMJ. In edentulous
patients, these are intended to be fitted over the
The guidance document also provides
warnings that the use of these devices may cause tooth
movement or changes in dental occlusion. That may be
a long‑term effect of using these types of devices.
Dr. Demko will be presenting on those
issues a little bit later, gingival or dental
soreness, especially the ones that need to be
individualized and custom impressions need to be
adjusted for each individual patient to prevent
impinging on the tissue.
And the pressure from the advancement may
cause some dental soreness, pain or soreness of the
TMJ with the advancement of the mandible. It may
stress the TMJ or the muscles surrounding the TMJ,
obstruction of oral breathing. And, as I have said,
we have required a mechanism for oral breathing on all
of these appliances in excessive salivation.
So what types of clinical studies has the
Dental Branch been reviewing? For simple snoring, the
studies have included performance measurements that
include the rate of reduction of snoring based on
clinical observation. This may be as simple as a
recording of snoring pre and post‑insertion of the
device measuring the intensity or loudness of the
For obstructive sleep apnea, the clinical
data includes baseline and post‑insertion
polysomnograms measuring the apneic events, the
apnea/hypopnea index, oxygen saturation, and other
measurements. These data are provided in a 510(k)
submission when there is a new design dissimilar from
designs previous cleared in a 510(k), new technology,
or new indication for use.
So what differences are there between the
Dental Branch and the ENT Branch in regulating these
devices? All dental devices for snoring and
obstructive sleep apnea are intraoral, and all are
prescription devices. That is, no intraoral dental
devices for the treatment of snoring and/or
obstructive sleep apnea have been cleared as
Also, due to the dissimilarities in
design, intraoral devices for both snoring and
obstructive sleep apnea pose similar risks based on
the correct selection and fitting of the appliance, as
opposed to perhaps an external nasal strip, for which
fitting is not as critical as the selection of the
correct device for the treatment of snoring and/or
obstructive sleep apnea.
As noted in Dr. Mann's presentation
earlier, the ENT Branch has cleared over‑the‑counter
devices for snoring and mild obstructive sleep apnea.
So why has the Dental Branch cleared these
devices as prescription‑only devices? These devices
present different risks perhaps from the ENT devices.
The devices are varied in design. As I have
discussed, there are three different designs that are
included in the regulation to date. Within those
designs, there are subsets of those designs. And also
sometimes there are combinations of the designs in one
And the application based upon the degree
of advancement may present some other risks. These
devices apply forces on the teeth, tissue, and the
temporomandibular joint, which makes correct selection
and fitting of the device along with adequate
follow‑up important in preventing injury.
Critical care by a dentist is critical in
the diagnosis of periodontal disease, decayed,
missing, and filled teeth, the maximum protrusive
range and the range at which the mandible should be
advanced, the status of the temporomandibular joint,
and also the diagnosis of parafunction, such as
clenching, grinding, which may impact the type of
device that is used and also the fitting of the
individual device. All of these assessments are
important to the safe use of these devices.
The Dental Devices Branch has received
clinical protocols from sponsors to support
over‑the‑counter use for the treatment of snoring and
anticipate receiving protocols also for obstructive
Some of the issues that have been
addressed in these protocols include the intervention
of a dentist or other competent intermediary to assess
the general health status, the oral health status,
and/or the appropriateness of the individual device
prior to the patient receiving the device.
The Dental Branch has not viewed these
protocols as representative of consumer use studies
for over‑the‑counter devices. For example, they do
not seem to reflect the experience of a consumer going
to a pharmacy, picking a device up off the shelf,
taking it home, reading the directions, fitting the
device accurately, and then being able to make an
assessment as to whether the device is the correct
device and also whether the device is effective.
Other issues discussed in these protocols
include lay person self‑assessment of snoring versus
obstructive sleep apnea and directions for use for
self‑fitting the oral appliances and self‑assessment
of the fit.
These are issues that we would like your
input in your discussion today to assist us in
determining what would be adequate protocols to
support over‑the‑counter use of these devices.
As Heather Rosecrans presented earlier,
over‑the‑counter devices require adequate directions
for use for the lay person. The questions that have
come to the Dental Branch's mind in looking at these
devices are: Can the lay person accurately
self‑diagnose their medical condition? Can the lay
person accurately self‑diagnose their oral health
status? And can the lay person choose the correct
oral appliance and fit it accurately such that the
device is safe and effective and does not cause
adverse events? And also are there different
considerations for snoring versus obstructive sleep
We have developed some questions to assist
you in your discussion today. What I would like to do
is present the three questions that we have developed.
These questions apply both to the dental and ENT
devices and just hopefully will focus the discussion
to assist us in gathering the information that we
would hope to receive today.
Question 1 is, as noted in FDA's
presentation, the following types of devices may be
considered for or have already been cleared for
over‑the‑counter status for the indications of snoring
and/or obstructive sleep apnea. Please discuss the
risks and benefits of allowing devices to be marketed
over the counter for the treatment of snoring and also
mild, moderate, and severe obstructive sleep apnea.
And, in particular, please discuss the
overall risk‑benefit ratio assessment as it relates to
the level of disease severity and discuss the
potential risks related to delay in professional
diagnosis and treatment resulting in over‑the‑counter
availability or use of these devices.
We have developed a chart to go along with
question 1, which lists the different types of
devices, and then the snoring and the different
degrees of obstructive sleep apnea and whether these
devices have been presently cleared as prescription or
Question 2, if after your discussion of
question 1 you believe that certain devices would be
appropriate for over‑the‑counter treatment of
obstructive sleep apnea, please discuss the following:
how adequate product labeling can be written to assist
the user in self‑diagnosing and differentiating the
severity of obstructive sleep apnea he or she is
experiencing to ensure proper use and also any other
general or specific labeling restrictions which you
believe would be appropriate for over‑the‑counter
devices to treat snoring and/or obstructive sleep
apnea; for example, any specific types of
contraindications, warnings, or precautions which you
believe should appear in the device labeling.
And then the final question is, please
discuss the following aspects of the clinical data
which may be appropriate to be included in marketing
submissions for snoring and/or obstructive sleep
apnea: a) the general clinical study design,
including control group, if needed; b) the endpoints
which would be acceptable for the assessment of the
effectiveness of treatment; c) the degree of
improvement for each of the endpoints which would be
clinically meaningful assuming an acceptable adverse
event profile; d) the specific adverse events, if any,
which should be carefully assessed by FDA from the
clinical trial; e) whether any of the responses to
3(a) through 3(d) would be different based on the
severity of snoring and/or the degree of obstructive
sleep apnea: mild, moderate, or severe; f) any
specific considerations in trial design for
over‑the‑counter indications; and g) any specific
device types or indications which would not require
clinical data. Again, we will put these questions up
later for you to assist you in your discussion of this
I want to thank you for the opportunity to
present today. And I will answer any questions if you
CHAIRPERSON GULYA: Thank you, Dr. Mulry.
I think in view of the time, what we will do is we
will hold questions for all of you speakers, Ms.
Rosecrans, Dr. Mann, and yourself, of when we start to
embark upon our deliberations. So thank you very
DR. MULRY: Thank you.
OPEN PUBLIC HEARING SESSION
CHAIRPERSON GULYA: Next on the agenda is
the open public hearing segment, for which we have 30
While I am going through the rest of this
material, I see that we have five presenters listed
here: Dr. Steven Merahn, Dr. Lawrence Epstein, Dr.
Kent Moore, Dr. Keith Thornton, and Mr. George Dungan.
If you would be so kind as to arrange yourselves in an
order so you could be proximal to the microphone so as
to minimize transition time in between speakers, that
would much appreciated.
The open public hearing segment provides
the opportunity for members of the public who have an
interest in addressing the panel on today's topic;
i.e., over‑the‑counter/prescription use for devices
for the treatment of snoring and/or obstructive sleep
Each presenter should state clearly for
the record their name; affiliation; interests in the
topic at hand; any consulting arrangements or
financial interest with medical device firms; and if
travel expenses have been paid, by whom.
Now, I have been asked by the FDA to read
this into the record. This is the introduction to the
open public hearing general matters meeting. Both the
Food and Drug Administration and the public believe in
a transparent process for information‑gathering and
decision‑making. To ensure such transparency, at the
open public hearing session of the Advisory Committee
meeting, FDA believes it is important to understand
the context of an individual's presentation.
For this reason, FDA encourages you, the
open public hearing speaker, at the beginning of your
written and oral statement to advise the Committee of
any financial relationship that you may have with any
company or any group that is likely to be impacted by
the topic of this meeting. For example, the financial
information may include a company's or group's payment
of your travel, lodging, or other expenses in
connection with your attendance at the meeting.
Likewise, FDA encourages you at the
beginning of your statement to advise the Committee if
you do not have any such financial relationships. If
you choose not to address this issue of financial
relationships at the beginning of your statement, it
will not preclude you from speaking.
So, as I said, we have 30 minutes for this
session. We have a number of speakers. And I
understand all of you have been asked to hold your
comments to five minutes. And out of fairness to all,
I ask you that you hold yourself to these limits.
I do have one of these neat little timing
devices that hopefully I can use without blowing this
all up. We will try and use that to help encourage us
to stay on time.
So we have as our first open public
speaker Dr. Steven Merahn.
EXECUTIVE SECRETARY S. THORNTON: Either
the podium or the table, whichever is more comfortable
DR. MERAHN: Good morning, everybody.
EXECUTIVE SECRETARY S. THORNTON: Dr.
Merahn, do you think we could dispense with the slides
at this time in the interest of time?
DR. MERAHN: I don't have slides. I'm
just going to read off my screen instead.
EXECUTIVE SECRETARY S. THORNTON: Okay.
DR. MERAHN: No, I wouldn't put you
through that. I'm a no PowerPoint.
EXECUTIVE SECRETARY S. THORNTON: Okay.
I wanted to make sure you got your full five minutes
DR. MERAHN: Okay. Good morning,
everybody. Thank you. Thank you for allowing me to
I am a physician and founder of the
American Academy of Sleep Disorders Dentistry, which
is a private education and professional services
organization with the objective of increasing the
number of patients identified and treated for
airway‑relate sleep disorders via collaboration
between physicians and dentists.
It is our position that a collaborative
interdisciplinary approach to sleep disorders
management offers the most responsible and effective
means of reducing the significant public health and
economic impact of obstructive apnea.
Our founding members include over 40
dental and medical professionals from all over the
country, mostly from working knowledge in the use of
oral appliances for the treatment of sleep disorders
as well as TMJ and other forms of craniofacial pain.
The academy is almost entirely funded by
fee for service for educational and professional
activities. I have no other related conflicts of
interest. And, in fact, the funding for my trip today
came out of my own pocket.
The specific question at hand today is
whether oral appliances for airway‑related sleep
disorders, such as snoring and sleep apnea, should be
permitted to be sold over the counter or should remain
On that question, our recommendation is
that they remain prescription devices, largely
because: first, the risks of self‑diagnosis are too
high. There was a complex differential diagnosis
associated with the signs and symptoms of
airway‑related sleep disorders, the primary symptom
excessive daytime sleepiness, is a symptom of many
serious medical conditions, including anemia,
hyperthyroidism, and others.
While we do not believe that a full
polysomnography is required to diagnose an
airway‑related sleep disorder, a trained health
professional and in our vision a physician‑dentist
team should be involved in the screening, assessment,
and diagnostic process.
Second, there are potential adverse events
related to the airway jaws. Tongues and teeth tend to
be associated with unmonitored mandibular positioning.
Oral appliances are serious therapy and can have a
significant adverse impact on airway function if not
properly fitted for optimal therapeutic efficiency.
There is no one size fits all solution. The
literature is quite clear that the efficacy is largely
a function of the degree to which the appliance is
titrated to patients' anatomy.
However, the issues underlying the
specific question in front of you today should not be
lost. The interest in over‑the‑counter status for
oral appliances is driven by the compelling need to
manage the overwhelming public health threat posed by
airway‑related sleep disorders.
As I am sure the Committee is aware, sleep
apnea affects millions of individuals, more than
asthma and diabetes and is increasingly recognized as
a cause of hypertension and cardiovascular events as
well as impairments of cognitive function,
interpersonal relationships, and workplace
Our academy recently commissioned a study
which looked at the public health and economic impact
of current treatment paradigms compared to our
collaborative therapy model. While these data are
being prepared for publication, I would like to share
one or two conclusions with the Committee.
While CPAP is the gold standard of
treatment with virtually 100 percent efficacy after
titration, the data on compliance does not support
CPAP as meeting the public health needs related to
There are some patients who with a more
properly fitted and evaluated oral appliance will
offer 100 percent efficiency without the burden of
disruption of CPAP, but for even those who do not
receive 100 percent efficiency, there is a compelling
reason to use oral appliances to manage OSA.
Our study developed a population impact
factor for each therapy, a therapeutic index derived
from fixed appliance data. For oral appliances, the
impact factor is 60 percent. While CPAP is
approximately 45 percent, this population impact
factor is derived from efficacy and compliance data.
Based on these findings, oral appliances
should be repositioned, so to speak, as a first‑line
therapy in a step‑wise approach to management using a
collaborative primary care model. This will
significantly reduce the costs associated with sleep
Untreated apnea adds approximately $1,800
to the lifetime costs associated with MI and stroke.
Based upon our population impact factor, oral
appliances will lower that cost to $650 while CPAP
actually only lowers it to $993.
If we substitute oral appliances for any
percentage of patients entering the system, we will
save significant amounts of money with little
epidemiologic impact. In fact, the academy supports
the increased use of oral appliances as first‑line
treatment for airway‑related sleep disorders in a
collaborative care model but does not support their
becoming available over the counter.
And while this may not be in the
Committee's purview, we recommend shifting the
responsibility for the treatment of apnea to an
interdisciplinary team of physicians and specially
trained dentists as a method to achieve the public
health objectives but alleviate the risks of
self‑diagnosis and unmonitored treatment associated
with OTC oral appliances.
CHAIRPERSON GULYA: Thank you very much.
DR. MERAHN: I can breathe now.
CHAIRPERSON GULYA: Yes, you can. Any
pressing questions from the panel for Dr. Merahn?
CHAIRPERSON GULYA: Okay. Thank you very
DR. MERAHN: Thanks.
CHAIRPERSON GULYA: We will next proceed
to Dr. Lawrence Epstein.
DR. EPSTEIN: Good morning. Thank you for
the opportunity to speak on this issue. My name is
Larry Epstein. I am Board‑certified in sleep medicine
and head a sleep medicine specialty group in Boston,
Massachusetts. I am instructor of medicine at Harvard
Medical School and the President‑Elect of the American
Academy of Sleep Medicine, the organization I am
representing today and who has paid for my travel
The AASM is the professional organization
for the subspecialty of sleep medicine. The AASM
publishes practice guidelines and diagnostic criteria
to help provide the best care for patients with sleep
I have no other financial conflict of
interest with respect to the issue of oral appliances.
Our organization and the individuals it
represents are concerned about the consequences of
possible over‑the‑counter use of oral appliances to
treat snoring and obstructive sleep apnea. Making
these over‑the‑counter devices will increase their
availability but likely will not improve the care of
patients with obstructive sleep apnea.
Oral appliances are valuable tools in the
treatment of sleep apnea. Multiple studies have shown
their effectiveness for mild to moderate but not
severe obstructive sleep apnea.
A review by the AASM using strict
evidence‑based review methodology, which is included
in our packet to you, which you should have, found
that oral appliances, though not as effective as
continuous positive airway pressure, were effective in
over half of the patients with sleep apnea. However,
they are not uniformly effective and have some
significant complications. For these reasons, the use
of oral appliances requires thorough evaluation and
follow‑up by medical and dental personnel.
Several more recent reviews, which include
randomized trials in larger numbers, have reaffirmed
the findings in the original review paper.
I would like to address two specific
questions from the Committee, though I have tried to
answer all of the questions in my written submission
to you. First, what is the ability of the patient to
self‑diagnose and treat sleep apnea? The most common
symptoms of OSA are snoring and daytime sleepiness,
which are sensitive but not specific for sleep apnea.
People trying to eliminate their snoring are often not
aware that snoring is a marker for the presence of
Differentiating snoring from OSA can be
difficult for a trained physician, much less the
patient. For example, in a young, non‑obese person
under 40 years of age, body mass index of less than
27, whose only symptom is snoring with no daytime
sleepiness or episodes of observed stopping breathing
at night, the chance of having obstructive sleep apnea
can still be up to 25 percent.
Additionally, since obstructive sleep
apnea occurs while the person is asleep and unaware,
people are poor judges of the presence of sleep apnea.
Use of an over‑the‑counter oral appliance may improve
the symptom of snoring but leave the apnea untreated.
I feel our organization is particularly
well‑suited to answer the next question. What is the
role of medical and dental providers in the diagnosis,
treatment, and follow‑up of snoring and sleep apnea?
It can be difficult to differentiate
between snoring and sleep apnea by symptom alone.
Multiple studies have shown that thorough clinical
evaluation plus objective testing, such as a sleep
study, are required to establish both the presence and
severity of OSA accurately.
Patients who try to eliminate their
snoring with an over‑the‑counter device might delay or
avoid appropriate evaluation and remain untreated for
sleep apnea. This increases their risk of developing
hypertension and other cardiovascular diseases and
increases the likelihood of workplace and automobile
accidents due to preventable hypersomnolence.
The FDA has approved over 30 oral
appliances for the treatment of sleep apnea or
snoring. They have different mechanisms and different
degrees of change in airway shape. It is essential
that a dental professional trained in the role of oral
appliances and the treatment of sleep apnea and
snoring as well as all aspects of oral health and
dental occlusion be involved in determining the
appropriate device and ensuring appropriate fit.
Although effective and well‑tolerated,
oral appliances are not always successful, often
require modification, and have both mild and
significant complications. Jaw and teeth discomfort
and excessive salivation are commonly reported and can
be resolved with dentist‑supervised adjustment of the
Later complications include
temporomandibular joint discomfort and changes in
occlusive alignment, which can lead to chronic pain
and difficulty eating. Follow‑up by medical and
dental care providers is essential for prevention and
treatment of these problems.
Because oral appliances are not successful
at eliminating sleep apnea in everyone, it is
essential that the patients be checked for
effectiveness of the device. Partial but ineffective
treatment can mask the preventive symptom of snoring
while leaving the most serious sleep apnea untreated.
The AASM has published a clinical practice
parameter based on evidence‑based literature review to
guide practitioners in the use of devices. This paper
is also in your packet.
Our recommendations include the following.
One, the presence or absence of sleep apnea must be
determined before initiating treatment. Two, oral
appliances should be fitted by qualified personnel who
are trained and experienced in the overall care of
oral health and temporomandibular joint, dental
occlusion, and associated oral structures.
Oral appliances may aggravate TMJ disease
and may cause dental misalignment and discomfort.
Follow‑up care by dentists is necessary to assess the
development in any of these complications.
In summary ‑‑
CHAIRPERSON GULYA: Okay. Thank you.
Summarize real quick, please.
DR. EPSTEIN: Okay. Oral appliances are
valuable tools, but they need to be applied and
managed by physicians and dentists trained in the
treatment of sleep disorders and the management of
dental health. Our organization and the practitioners
it represents requests that you not change the
guidelines at this time and do not make them
CHAIRPERSON GULYA: Thank you. Next we
will hear from Dr. Moore.
DR. MOORE: Good morning. My name is Kent
Moore. I am a Board‑certified oral surgeon. And a
segment of my practice in Charlotte, North Carolina
focuses on treating patients with sleep‑related upper
airway breathing disorders. I am the mediate past
Chairman of the American Association of Oral and
Maxillofacial Surgeons Clinical Interest Group on
Sleep‑Related Breathing Disorders and Obstructive
Sleep Apnea and currently serve as the President of
the Academy of Dental Sleep Medicine.
The ADSM, the international organization
representing general dentists, physicians, oral
surgeons, orthodontists, prosthodontists, and
pedodontists sharing a specific interest in oral
appliance therapy and jaw surgery for treatment of
sleep‑related breathing disorders, is grateful for the
opportunity to address the FDA regarding consideration
of over‑the‑counter use of oral appliances.
I have no financial interest in this
discussion, and my travel expenses have been paid for
by my academy.
The ADSM is strongly opposed to OTC use of
oral appliances and feels that allowing OTC use would
present a significant risk to the greater public
health. We do not feel there is sufficient data form
the body of scientific and professional literature
that substantiates the safety and efficacy of oral
appliances utilized in this manner and recognize that
unsupervisied utilization of these types of appliances
will cause significant morbidity to the population
involved as well as have detrimental effects in
preventing or delaying the diagnosis and proper
treatment of the underlying sleep‑related upper airway
The explanation for this position is
clarified blow in our response to the specific
questions asked by the panels. That is, what is the
role of the medical/dental provider in the diagnosis,
treatment and follow‑up of snoring and sleep apnea?
The ADSM's clinical treatment protocol,
which is attached in our written documents, documents
our position that the diagnosis or absence of OSA and
differentiation of primary snoring from OSA can only
be performed by a qualified sleep physician and
treatment therein coordinated and directed by the
diagnosing sleep physician. Referral from the sleep
physician after proper diagnosis is made to the
treating dentist is necessary prior to fabrication of
an oral appliance. These recommendations adhere to
the current American Academy of Sleep Medicine
Clinical Practice Parameter.
Much of the effort of the ADSM is directed
toward training our membership regarding the
complexities of upper airway pathophysiology and need
for sleep medicine. In order to modify complications
of therapy, once an oral appliance has been
fabricated, the patient must be followed clinically
for the length of time that the appliance is being
What is the ability of the patient to
self‑diagnose and treat obstructive sleep apnea?
Properly diagnosing the presence and severity of upper
airway disorders is a complex and potentially
complicated exercise. The position of the ADSM is
that accurate self‑diagnosis on the part of the
patient is not a reliable method for diagnosis.
People trying to eliminate their snoring
are often not aware that snoring is a marker for the
presence of OSA. Differentiating snoring from OSA can
be difficult for sleep physicians without the use of
objective testing, much less an untrained person.
Use of OTC oral appliances may improve the
symptom of snoring but leave the OSA untreated,
exposing the person to the risk of developing
hypertension and cardiovascular disease as well as
increased rates of workplace and motor vehicle
Also essential prior to treatment is the
need for proper diagnosis of the severity of the upper
airway disorder in order to help direct the proper
intensity of therapy. The literature documents that
oral appliances are statistically more beneficial in
patients with mild to moderate OSA; whereas, those
patients with more severe degrees of OSA possess a
less statistical chance of obtaining a cure with oral
Allowing any user to obtain an OTC version
of an oral appliance and treat themselves without
proper diagnosis exposes many patients to potential
under or inadequate treatment of their airway
Additionally, when a user fails to get an
adequate response from a fixed position OTC version of
oral appliances, their willingness to pursue a more
professional and therapeutic version of an oral
appliance will most likely be tempered.
Data regarding safety and efficacy of oral
appliances utilized in this OTC manner, preferably
performed by entities devoid of a profit motive or
other conflicts of interest, would be required prior
to an OTC intended use decision. Data to this effect
is currently lacking. The long‑term impact of oral
appliance therapy on TMJ function within the body of
scientific literature also is currently lacking.
Adequate device labeling would require
complete descriptions of the symptoms, causes, and
consequences of obstructive sleep apnea; the need for
appropriate medical evaluation for OSA, including the
differentiation of primary snoring from OSA and the
relationship of snoring to OSA; and an overview of the
mechanisms of oral appliances.
Consumers would need to be warned that
treating their snoring may not eliminate OSA, even
without other symptoms being present, resulting in
silent apnea. Patients should be advised to contact
their health care providers for any suspicion of OSA
or if the devices are unsuccessful in eliminating
Consumers would also need to be warned of
the following serious potential adverse events, as
mentioned by a previous speaker. True, there are OTC
appliances available to the public for treatment of
tooth grinding or bruxism, but these appliances are
not being asked to do what an advancement appliance is
doing and do not bear the same type of forces being
brought to bear for patients with OSA. Considering
these forces, the potential for adverse effects is
greatly magnified compared to these bruxism or mouth
In conclusion, the ADSM strongly opposes
making oral appliances available for OTC use. Oral
appliances can be effective therapy for snoring and
OSA, particularly in mild to moderate, severe OSA.
However, the difficulty in differentiating between OSA
and snoring, the need for clinical evaluation and
physiologic testing and the potential for significant
complications listed above, particularly in lieu of
clinical data showing safety and effectiveness in an
OTC model, make it essential that oral appliances be
provided under the direction and care of medical and
dental personnel trained in the management of patients
with sleep disorders.
CHAIRPERSON GULYA: Thank you, Dr. Moore.
Any questions from the panel for Dr.
CHAIRPERSON GULYA: No. Okay. Thank you.
DR. K. THORNTON: Thank you. I'm Dr.
Keith Thornton. I'm in the private practice of
dentistry in Dallas, Texas. I am the owner of Airway
Management, Incorporated, which makes the TAP oral
I also have a number of other inventions.
I am now part of the visiting faculty at Baylor
College of Dentistry Department of Orthodontics. I
have taught there in treating temporomandibular
disorders and have taught at Pankey Institute the last
30 years. I am a consultant to Wilford Hall and to
the Army in oral appliances and have worked for a
number of people, including the Academy of Dental
My issue today really is to come and say
as a practitioner, I have treated probably 300
patients a year for the last ten years. And I have
given some pictures to you of the morbidity that is
caused by these devices. The device that I have
developed can move the jaw beyond maximum protrusion
in what we call passive stretch position, must beyond.
If you look at the publication by Jeff
Pancer and the editorial afterwards, it says now that
we can treat severe sleep apnea ‑‑ and that is what we
are treating. That is who I treat. I treat the
people that are non‑compliant severe sleep apneics.
In that picture, as you see, the patient
was a 95‑year‑old patient that is in Class I occlusion
when I started treating him in '93. By '97, he was
seven millimeters forward of that position. And that
was a permanent position.
He stopped wearing the appliance in about
'99 to 2000. And he has not worn the appliance since.
He has no sleep apnea, and it is almost like I did
orthomatic surgery on him.
I have seen that in about four and a half
percent of my cases. It is a frightening thing when
we see that. I have decided not to take my device and
make it even a non‑custom appliance because I do not
feel that it needs to be in the hands of anybody that
is a non‑dentist. And I am talking about physicians,
anybody else that is a non‑dentist, even a
professional. So my determination as a company is to
keep it within the dental profession.
As far as the warnings and labeling, we
have just finished going through our booklets on
clinician instructions and made a lot of changes,
including in our packets, some really significant
things that I think are important.
One of these you will see in the next
pictures over are pictures of what we call our
exercise bite tabs. They go into every one of our
boxes. And it's one of the things that when I teach
dentists ‑‑ and I have taught at all of the meetings.
I said the most critical thing that you do
every morning is get the mandible back in the right
position and teach the patient so that they can feel
their back teeth every morning. If they don't do that
within three weeks, I've seen it where they cannot get
their teeth back into centric occlusion where they
can't get their back teeth together.
We are now working with the head of the
Orthodontic Department and looking at doing dog
studies in effecting what we are really doing with
this jaw joint and how it functions. It can cause
very significant morbidities. As a practitioner and
as a manufacturer, I don't think it is ethical for me
to come out with something that is any less than a
device that is made by dentists.
CHAIRPERSON GULYA: Thank you very much,
Do we have any questions for Dr. Thornton?
CHAIRPERSON GULYA: Thank you. And,
lastly, we will have Mr. George Dungan.
MR. DUNGAN: Thanks very much for the
opportunity to participate today. Respironics is a
leading manufacturer of sleep and respiratory
products. I'm the manager of clinical affairs, and
I'm here in that capacity.
Our focus at this meeting concerns two
important opportunities to improve patient care;
specifically, over‑the‑counter treatment of snoring
with appropriately tested and effectively used oral
appliances and over‑the‑counter use of screening tools
for sleep apnea. As you have heard, sleep disordered
breathing affects millions of Americans and is largely
under‑diagnosed and under‑treated.
Obstructive sleep apnea affects at least
18 million Americans, with up to 80 percent
undiagnosed currently. At the other end of the sleep
disordered breathing spectrum, snoring is a noxious
condition that often prompts some intervention or at
least accommodation by sufferers.
Many OTC treatments are promoted for the
treating of snoring, although none have proved
clinical evidence as to their overwhelming efficacy.
On the other hand, efficacy has been established by
the many prescription devices that have been cleared
by the FDA to treat snoring. Many of these are oral
appliances, the safety and efficacy of which have been
demonstrated through clinical trials over the past ten
OTC clearance for oral appliances to treat
snoring focuses on two questions: first, whether the
treatment of snoring would prevent a user from seeking
treatment for a potentially more serious condition,
such as OSA; and, second, whether a user can
successfully choose, fit, and treat the snoring on
their own. Both of these risks are mitigated through
education and labeling.
The ability of adequate instructions in
labeling to permit the safe and effective use of OTC
products has been demonstrated by the numerous
clearances associated with other OTC medications and
devices. These products show that consumers can
readily understand when a medication or device is
right for them, how to properly use the product, and
when to seek medical assistance.
The same model can be applied to an OTC
oral appliance. Such devices will need to include
specific warnings and educational information for
determining proper fit and use of the appliance.
Further, labeling and instructions should
help users identify obstructive sleep apnea. The
instructions should direct patients to seek medical
attention if they currently have symptoms of OSA, if
their condition does not improve, or if they
experience discomfort or side effects from use of the
device. We believe that any OTC device must also
include a clear directive to the patient to include
the appropriate clinician as a partner, even in their
FDA clearance of an OTC oral appliance
should be supported by adequate clinical data,
demonstrating the safety, efficacy, and useability of
the device. These data would need to be submitted to
the FDA for review prior to clearance and should
address the following: compliance with FDA guidance
on oral appliances; studies of long‑term effects of
continuous use of the device; demonstrated therapeutic
efficacy; and, finally, demonstrated useability.
An important consideration for the use of
OTC appliances is the adequate identification of the
likelihood of obstructive sleep apnea. Thus, OTC
screening for OSA is tied to these appliances.
Patients pay a key role in their own transition for
personal awareness to diagnoses. To help aid in that
transition, we feel that tools raising awareness can
help patients overcome that barrier.
The availability of at‑home OTC screening
devices for OSA will enable patients to move more
readily towards appropriate diagnosis and treatment by
a clinician. Failing to substantially address OTC
screening may, in fact, perpetuate significant
under‑diagnosis of OSA.
Such OTC devices for use in the home by
untrained patients would need to meet several
requirements. First, the device must have the
appropriate level of sensitivity to identify sleep
apnea while maintaining a low rate of false negatives.
Manufacturers should provide the FDA with clinical
data comparing the results of the OTC use in the home
to the results of subsequent formal diagnostic
Second, user validation studies should be
submitted to the FDA, demonstrating that the patient
can properly determine that the device is appropriate
for their signs and symptoms; use the device;
understand the labeling; and, finally, understand the
We feel very strongly that any OSA
screening device should deliver unambiguous results,
results that are not subject to interpretation such
that a patient would definitively know whether to seek
further medical assistance for their OSA.
CHAIRPERSON GULYA: You need to be
MR. DUNGAN: In summary, Respironics
believes that the OTC availability of oral appliances
for snoring and, finally, oral screening aids is
extremely important to reach a large at‑risk
under‑served population. When supported by proper
data, these two types of products can offer
significant benefits to patient management.
CHAIRPERSON GULYA: Thank you, Mr. Dungan.
Any questions for Mr. Dungan?
CHAIRPERSON GULYA: Okay. Well, with
that, our open public hearing session draws to a
close. I thank our public speakers for the
information they have taken the time and trouble to
bring to the panel. I would like to turn to Sally
first to see if she has any announcements or anything
for the panel.
EXECUTIVE SECRETARY S. THORNTON: I don't
think so, not at this time, except to say that there
will be a second open public hearing session this
afternoon of a half‑hour duration. And we do have one
speaker at that time.
CHAIRPERSON GULYA: Well, with that, the
panel has already had a pretty busy morning. I
propose we take about a 15‑minute break and plan on
being back here at 10:30. Thank you.
(Whereupon, the foregoing matter went off
the record at 10:17 a.m. and went back on
the record at 10:35 a.m.)
CHAIRPERSON GULYA: We now have two panel
presentations, the first of which will be by Dr. David
Terris. Dr. Terris?
DR. TERRIS: Thank you.
DR. TERRIS: Good morning. It's an honor
to have the opportunity to address this distinguished
group about several issues. I was asked to take sort
of an evidence‑based approach to answering multiple
issues. I want to start by thanking Kenny Pang, who
is our sleep surgery fellow with the Medical College
of Georgia, who helped with a lot of the background
So there were three specific issues I was
asked to focus on. The first lends itself last to an
evidence‑based approach, which is simply a defined
occurrence of standard of care for diagnosing sleep
apnea; secondly, to consider the issue we have heard
about already, which is, are patients capable of
diagnosing themselves with having sleep apnea based on
a series of signs and symptoms; and, then, finally, a
related issue, which is, can they, therefore, monitor
the effectiveness of treatment utilizing those same
signs and symptoms and how does that correlate with
objective measures of success?
I actually think it is quite important to
spend just a few minutes talking about the importance
of the diagnosis and treatment of sleep apnea. We
have heard a little bit about this.
The cardiovascular impact we know from the
sleep heart health study now, quite definitely, the
impact of sleep apnea, the neurovascular risks, and
the risks for motor vehicle accidents. This is an
older study but quite clearly shows the impact of
sleep apnea on mortality. This is from 1988, patients
with an apnea index of more than 20 or less than 20
over time untreated, you can see what happens
independent of other comorbidities. This is the
mortality, the cumulative survival on the y‑axis.
The sleep heart health study is a very
important study put on by Susan Redline and her
colleagues at Wisconsin. There has been a series of
publications related to this study of over 6,000
subjects enrolled. All underwent ambulatory
polysomnography. And the most important finding was
a very strong correlation of sleep disorders with
cardiovascular disease independent of other risk
We know about driving while sleeping.
It's a terrible problem. National Highway
Transportation Safety Administration estimates over
50,000 accidents, with 1,500 deaths, due to sleep
drivers. Again, this is something we are all familiar
Something else most people are aware of is
the Exxon Valdez crisis, but what many people don't
know is that ten years after the catastrophe, it was
determined that this was caused by a sleep captain of
that ship who probably had an underlying sleep
disorder, so very significant ramifications.
The scope of the problem, we know that the
society is becoming more obese, resulting in increased
prevalence of sleep disorders and, therefore,
proliferation of products to treat this problem.
This simply represents this advancing
creep of obesity in society. Of course, coming from
Georgia, I am particularly concerned about the dark
green because that is more obesity. They are most
closely associated with the prevalence of sleep apnea.
Not everybody thinks this is a problem,
DR. TERRIS: Well, again, proliferation of
a number of different products. The snore pills,
which come in a regular or allergy‑type modification;
the snore sprays, which are typically emollients that
lubricate the upper airway; and one that we're going
to consider I guess today, which is nasal strips, the
Breathe Right strip. We have heard a little bit about
that. It's important to make sure it's placed
accurately and depending on the nasal architecture,
make sure you have enough of them.
DR. TERRIS: Oral appliances I'm going to
just skip through this. There's a number of different
products available, which have different ways that
Okay. So getting to the issue of
polysomnography, this was first described in the
1950s, popularized by Dement of Stanford in the 1960s
and really is considered the gold standard today. And
this is what we're talking about. Level I attended
polysomnography has a series of monitors that are
placed: an EEG monitor to confirm that the patient is
in sleep; EOGs to test for REM sleep; EKG monitor,
self‑explanatory; EMG to evaluate for periodic leg
movements, snoring sounds, nasal and oral air flow;
and then plethysmography for chest and abdominal
movements, as well as pulse oximetry and positional
I have some personal experience with this
particular modality, having had a sleep study myself
about ten years ago, prior to having some minor
This is what it felt like the day after
the study. This is now sleep like you would at home
after being hooked up to these monitors. So it's a
quite involved process.
This is the information that is obtained
from the sleep study. So we know that the patient is
asleep. We see increasing respiratory effort but no
air flow in this patient having an apnea. Therefore,
they have a corresponding drop in their oxygen
Therefore, the brain has a choice to make.
It wants to stay asleep, but it also need oxygen. So
ultimately it usually makes the right choice and
awakens so that the muscles surrounding the throat
regain tone and you reestablish air flow. And,
therefore, the oxygen saturation can go back up to
So this is standard polysomnography. And
that's in an attended in‑hospital study. Ambulatory
polysomnography, which you have heard a little bit
about, typically involves at least four channels
looking at pulse rate, oximetry, some type of measure
of air flow, and then abdominal or chest movement.
This is I think a very good way of
diagnosing sleep apnea. Again, this is the modality
that was utilized in the sleep heart health study.
However, the ASDA has come out with a position
statement in 1994 that ambulatory monitoring is no
substitute for attended Level I polysomnography with
the exception of rare circumstances, patient can't get
to a lab or there is some contraindication to an
attended in‑house study.
There are a series of screening devices
that are being investigated. Pulse oximetry has been
utilized quite frequently. There are a number of
studies examining this particular modality with
sensitivity ranging from 23 percent to 90 percent.
That is part of the reason why this is really
considered to be a non‑realizable technique for
diagnosing sleep apnea.
A couple of more promising techniques.
The Watch PAT device is a finger‑mounted optic
pneumatic sensor. It actually detects obstructive
events from the sympathetic events that are caused by
the obstruction. There has been some promising
correlation with full polysomnography and then another
Then let me just give full disclosure. I
have no financial interest in the company that makes
SleepStrip, but I am about to start a study looking at
this as a screening device. So this is an upper lip
adhesive device that has flow sensors and oximetry
and, again, some promising early data that we are
going to try and evaluate.
So issue number one was an easy one for
me: the standard of care for diagnosis of sleep
apnea. It's polysomnography. I am quite certain that
Dr. Epstein and his colleagues would agree with that
from the sleep medicine world.
The second issue was the possibility of
patients self‑diagnosing sleep apnea. First of all ‑‑
and this would be related to the signs and symptoms of
sleep apnea. So let's make sure we know what those
are. Snoring, excessive daytime somnolence, and
witnessed apneas are the three mainstays. There are
a number of other symptoms that patients can present
with, including morning headaches, irritability,
neurocognitive deficits, including memory impairments,
impotence, and nocturia, particularly in children.
In addition to those signs and symptoms,
there are other so‑called risk factors for developing
sleep apnea, so advancing age, gender. Being male is
not a good thing. Body mass index. So that's the
weight of the patient and then neck circumference. So
we know that these are associated with the development
of sleep apnea.
So looking individually at the three
primary symptoms, snoring to start with, there is
quite a strong correlation of snoring with sleep
apnea, but you can see it's as low as 72 percent, as
high as 87 percent in a number of studies that have
looked at this as a specific symptom of sleep apnea.
Probably the best way for evaluating
excessive daytime somnolence in an easy fashion is the
Epworth Sleepiness Scale. It's the most commonly
utilized tool for assessing sleepiness. But even
this, 41 percent only of 440 snorers with an elevated
Epworth scale score have sleep apnea, 61 percent in
another study, so, again, not a very good predictor of
the likelihood of having sleep apnea.
What about witnessed apneas, which is
another common finding more commonly seen in patients
with sleep apnea but, again, not a one‑to‑one
correlation? So armed with some of this information,
a number of investigators have attempted to develop
models for predicting sleep apnea, again based on
either symptoms and/or some of the other risk factors
that I mentioned.
This was one study of 410 patients with a
relatively complex algorithm. And you can see only a
46 percent positive predictive value in diagnosing
Another study with slightly better data,
427 patients, again, acknowledging snoring, witnessed
apneas, gasping, age, gender, BMI, found only a 60
percent sensitivity in diagnosing sleep apnea.
And then the larger study of 744 patients,
somewhat better results, a more complex scoring
system, but you can see 86 percent sensitivity, 77
percent specificity, 89 percent positive predictive
So based on this evidence‑based review, I
would say one cannot reliably predict the presence of
sleep apnea without performing some type of
And then the final issue is, again, a
related issue. Can we determine the effectiveness of
treatment by evaluating signs and symptoms of sleep
apnea? I'm just going to show three of many studies
that would suggest that that we can't do that.
So this was an earlier study from Shiro
Fujita, who did a lot of the early work with surgical
interventions with sleep apnea. This was on
palatopharyngoplasty. He was one of the first to
recognize that even in his group of 31 patients, even
patients who had improvement in their sleepiness may
not have improvement in their polysomnographic
evidence of sleep apnea, so creating what was referred
to earlier as the so‑called silent sleep apneic.
Nelson Powell in Palo Alto has done a lot
of work with radiofrequency ablation of the palates.
In this study of 22 patients, they showed no change in
the polysomnographic parameters in their patients, but
the snoring improved by 77 percent and the sleepiness
improved in 39 percent. So, again, the patients are
going to feel better, but they may not be better.
And then our own data looking at hyoid
myotomy, genioglossus advancement, and palatal frontal
plasty, 32 patients, again, we have very good
improvement in the sleep but not as good as we got in
the snoring and the sleepiness. So that's one reason
why these patients do need to be followed up
post‑surgically and reevaluated with polysomnography
after any surgical intervention.
So, to finish off, improvements in the
signs and symptoms of sleep apnea often occur in the
absence of objective evidence of improvement in sleep
CHAIRPERSON GULYA: Thank you very much,
Do any of the panelists have questions for
Dr. Terris? I think we will have an opportunity to
readdress some of these issues when we go into our
deliberations over the questions as well. Yes?
DR. ROSENTHAL: Dr. Terris?
CHAIRPERSON GULYA: Could you please give
DR. ROSENTHAL: Rosenthal, Division
Director. That was an excellent presentation. Can
you tell us something about the longitudinal nature of
this condition? Do people progress from mild to
moderate to severe over time?
DR. TERRIS: Yes, it gets worse over time
for a lot of different reasons, primarily related to
increasing weight and laxity of tissue. So it's one
of those progressive diseases, chronic diseases, over
CHAIRPERSON GULYA: Yes?
MEMBER ZUNIGA: John Zuniga. Related to
that same question, is there a percentage of patients
that go from mild to severe and vice versa without
DR. TERRIS: I'm not aware of a single
patient that went from severe to mild without
treatment depending on how you define treatment. I
just saw a patient in the office the other day who had
a gastric bypass, which I consider treatment for sleep
apnea, and lost a couple of hundred pounds and went
from an RDI of 90 to an RDI of 3. So if you include
that as treatment, then no, I have never heard of that
ever happening. But to go from mild disease to severe
disease, yes, it happens with regularity.
CHAIRPERSON GULYA: Yes, Dr. Woodson?
DR. WOODSON: Gayle Woodson. Now, you
have patients who say they feel better but are not
better. If you have someone who does feel better and
he's functioning better, then there's a disconnect
between the functional results of it and the
Now, have you looked at like sleep onset
time because that is one objective measure of whether
or not they're really less sleepy, rather than just
saying they're less sleepy because they don't want
DR. TERRIS: Yes. Well, the problem is
it's not ‑‑
CHAIRPERSON GULYA: Please identify
yourself for the transcriptionist. They're trying to
DR. TERRIS: That was Gayle Woodson. I'm
EXECUTIVE SECRETARY S. THORNTON: Yes. I
think once around for everybody clearly into the
microphone will be enough for the transcriptionist.
CHAIRPERSON GULYA: Okay.
EXECUTIVE SECRETARY S. THORNTON: Thank
DR. TERRIS: The problem is that it's kind
of like hypertension or diabetes. I mean, if you ask
a patient with hypertension, "Do you feel badly," they
say, "No. I feel fine." But, nevertheless, this is
a chronic disease that is taking its ‑‑ exacting its
toll over years. So to me, yes, there are better ways
or good ways to carefully document if the sleepiness
has gotten better.
On the other hand, even if the sleepiness
is better, they can still have the cardiovascular
ramifications of the obstructive events occurring
frequently during the night.
DR. WOODSON: Yes. But isn't the evidence
for the cardiovascular kind of epidemiologic and a lot
of it is snorers have more strokes? There's not that
much good prospective data about people documented to
having sleep apnea and the results.
So specifically somebody who objectively
in a lot of ways is not better. Is there a
possibility he might not be having as much sequelae?
I mean, we don't have the data to say that, really.
I mean, it just makes sense compared to hypertension,
but we don't really have that data, right?
DR. TERRIS: I'm trying to think if that
specific study has been done. And if anybody else on
the panel is aware of it, please speak out.
DR. LI: Kasey Li from Stanford. I just
want to make a couple of comments. One, the
improvement that you see in some of these studies,
none of them are from placebo‑controlled. So they're
So, one, you have to look at the
possibility of placebo effect on improvement of
symptoms. That's number one. Number two, a lot of
times you see short‑term improvement in a matter of
three to six months in terms of functional
improvement. They have relapse. And even though they
may have some improvement, that doesn't mean that they
have resolution of the disease. So the improvement in
snoring doesn't really reflect, as you see in the
literature, an improvement or resolution of sleep
There are a lot of epidemiology studies,
two large studies from Wisconsin Cohort as well as the
National Heart Lung study looking at specifically and
demonstrating that sleep apnea is an independent risk
factor, I think, for cardiovascular disease.
So I think that the evidence is fairly
profound sleep apnea by itself significant affects the
well‑being of the patient.
CHAIRPERSON GULYA: Thank you, Dr. Li.
DR. TERRIS: I certainly would agree with
all of those comments. I guess it still doesn't get
at Gail's question of if the patient feels better and
their sleepiness is better, even if they have
polysomnographic evidence of sleep apnea, is their
risk of cardiovascular disease diminished?
Again, I don't know whether that study has
been done, but I can't imagine that that would be the
case. That's the only way. I would say that.
CHAIRPERSON GULYA: Okay. Well, thank you
very much. We will now hear from Dr. Demko.
DR. DEMKO: Thank you.
My name is Gail Demko. I am a dentist in
private practice. And my practice has been limited to
treatment of patients with obstructive sleep apnea
since 1997. What I am going to talk about today is
oral appliance side effects and how I use that in
patient selection, appliance selection because there
is no question about it. Of all of the patients that
are referred to me, I treat fewer than 75 percent of
them. And I am going to go fast.
What I want you to worry about is what
everybody else has been talking about, symptom
responders. This is from Anette Fransson's Ph.D.
thesis in Sweden, where patients who are given oral
appliances and were subjectively better when tested
polysomnographically, it was found out that they were
not better. So even though the patients felt fine,
The majority of the appliances on the
market are mandibular repositioning devices. Their
job is to bring the jaw forward and keep it closed.
Those two movements open the airway, both
retroglossally and behind the soft palate.
What I worry about is the more you open
that mandible, the more it is going to be in a
rotational mode. The more it rotates where the
genioglossus attaches at the anterior portion of the
mandible, the more it is going to rotate backwards and
close the airway.
So one of the things in choosing an
appliance, one has to look at how much do you have to
open that patient to get an effect? This is a typical
ceph on a patient of mine with and without an oral
appliance. The more you open him, the more you are
going to have to bring him forward, which is basically
what this person is saying.
So there are short‑term changes with
appliance use. There are long‑term changes.
Short‑term many times is just self‑resolving. The
excessive salivation occurs when a patient can close
around an appliance because it is small enough.
Other patients will complain of dry mouth
because they cannot close. But the bulk of the
appliance is so big that they have lip incompetency
and now are mouth breathing, which is basically what
I don't want a patient to do because nasal breathing
makes the appliance work better.
Pain in individual teeth happens almost
always in patients who have teeth with very sharp
edges, very crooked teeth. It can be that the model
that I sent to the laboratory was worn in shipping,
the impression was distorted, or that when the patient
took a boil and bite appliance home, if they got them
over the Web, which they can illegally from England
and Canada, that if there is contact with the edge of
that tooth and the hard outer shell of the boil and
bite, there will be pain. Very simple. Adjust the
Pain in the anterior teeth that the
patient is clenching, clenching forces can often
intrude teeth. Again, I want to make sure that that
patient has contact all the way around on the arch, at
least in a tripod configuration.
The mobility of the anterior teeth is
extremely common from the forces of the mandible being
forward by virtue of the appliance pulling it forward,
the muscles pulling it back. I will always go in and
adjust an appliance on the facial aspect of the upper
anteriors and the lingual aspect of the mandibular and
take those forces off the teeth. It doesn't stop them
from moving, but it stops them from being mobile.
Posterior open bite in the morning. There
are always arguments about why this happens, but
Fernanda de Almeida has done MRI studies where as that
mandible is moved down and forward out of the socket,
you actually will get edema in the joint space. Some
theorize it's shortening of the internal lateral
pterygoid, but that couldn't happen as quickly as this
fluid buildup is. And within two to three weeks,
patients will have evidence of a posterior open bite,
where their anterior teeth are the only things that
contact because the fluid is holding the condyle down
I have patients who will chew bubble gum,
just clench, but I tell them that that fluid needs to
be gone in 15 minutes after they get up in the morning
or there are going to be problems later on. It
doesn't prevent problems later on, but it seems to
Patients who have joint pain bilaterally
I find that predominantly it is excessive mandibular
advancement, which for some patients may be anything,
but it's beyond the ability of the joint structures to
tolerate. In some cases just setting the appliance
back further is fine and takes care of the problem.
In some places, they will have to discontinue care.
If they have unilateral pain, it seems
more often it is an eccentricity so that the mandible
is off to one side. Once you line up their midlines
or however they are naturally because patients can
deviate as they open and close their mandible, you
want to match that movement with your appliance, that
just moving the appliance one way or the other will
solve that problem.
There are allergic reactions, people who
are nickel‑allergic, latex‑allergic, and methyl
methacrylate. All three of those things are in
various appliances, and patients do need to be warned
Things that worry me: long‑term changes.
These long‑term changes do not normally become obvious
for a year. Anything that happens within six months
of wearing an appliance seems to be self‑resolving if
the appliance use is discontinued. After that, all
bets are off. These changes are permanent.
So in this case, I have gotten patients
who have developed all sorts of fibromas from hitting
the edges of appliances. What I did with this, the
patient had to go to the oral surgeon, have the
fibromas removed. We redesigned the appliance so
there was no more irritation of soft tissues.
Hard tissues changes are related to
incomplete coverage of the dental arch ‑‑ we argue
about this at all meetings ‑‑ and related pressures on
the dental arch because these appliances are basically
functional orthodontic appliances. The big deal is
that transceptal fibers, which sit in the roots around
the teeth, are the fibers that kick off orthodontic
And once they are activated, they transmit
forces around the arch, even away from where the force
is originally brought. And they will continue to act
24 hours a day with or without forces being brought.
So you will have with incomplete coverage
block movement of teeth. So this is just showing that
I could take a model where the floss could go between
those last two teeth. Open contacts are fairly small
in most instances, solve that by redesigning the
appliance or changing it to make sure that the back
molars are hooked around to now when you move the
teeth, you move all of them, as opposed to leaving two
We know that there is anterior tooth
movement. Rich's article, Rose's article, Marklund's
article, all of them will tell you anterior tooth
movement. The forces brought on those teeth take the
maxillary teeth, make them more upright, take the
mandibular teeth, and actually move them towards the
What I will see over periods of time is
opening interdental spaces. And this is a combination
of effect, but it is from those transceptal fibers.
The only way to put these patients back where they
started if that's possible would be orthodontics.
However, with so many of these, the posterior teeth
extrude into position. And now they are locked
forever in that bite.
Again, the fluid build‑up is a short‑term
change that can lead to long‑term changes because as
the condyle is held out of the fossa, the space that
that creates, the posterior teeth will extrude and
either keep it so the patient ‑‑ this is a physician.
He is so happy with this appliance, he refuses to give
Again, I don't see this type of movement
as often as other people do because I am really riding
patients hard. He has had spacing in his teeth. He
has had advanced modal, almost a quarter of an inch,
in his mouth.
This is a patient that used to be an
anterior grinder and wear his teeth. And now he can't
even touch his front teeth anymore. This is a patient
who was wearing an appliance, had mandibular
advancement. They put her in orthodontics. She had
a bridge on the upper that wouldn't move. They put a
lingual wire on the bottom so those teeth wouldn't
move. And after her orthodontics, she had a lovely
anterior open bite.
So there is a disagreement now among us as
to do materials of the appliance, do thermal active
acrylic appliances, Klearway, PM Positioner, or others
that you will heat up every night to put them in, move
teeth more than hard acrylics? There is no published
data that appears definitive on that.
Does moving the patient's mandible forward
seem to matter? Big deal. The statistical studies
show us that 75 percent advancement within the
patient's individual physiologic range seems to be the
most effective position. However, that really means
as statistics look only at large groups, that my
patients have been successful anywhere between moving
them 50 to 125 percent of their normal range.
So statistics tell us anybody who can't
move his jaw six millimeters, an appliance is not
going to be effective that moves the jaw forward. And
patients' ranges will vary from 4 to 18 millimeters.
The further you move them, the more likely there are
Chris Robertson is looking at statistics
again, not individual cases, on how many patients
move. The permanent movement of teeth begins between
6 and 12 months, and it continues past 30. He's up
now to two more years of data. It is not published.
He keeps the same original cohort and crunches
different things and publishes lots of articles.
This is a patient who bought her appliance
online from overseas. The same thing happens to these
boil and bite appliances as happens with the
prescription appliances that in this country are
available from dentists.
What I don't like to see is anything that
does not completely cover the mandibular teeth
completely. When you have these lingual flanges, the
forces on those lower anterior teeth will actually
avulse the teeth, even if they were healthy to start
What you want to be aware of is that there
is a significant decrease measured in the overjet and
overbite. And in a Pantin study, only two of nine
patients who had total lack of contact on their
posterior teeth even noticed this. Again, in Pantin,
fewer than half of his patients with occlusal changes
were aware that their teeth didn't hit like they used
to because these changes are so subtle.
Tongue retaining devices are also on the
market. There are very few of them. They are not
without problems. The majority of practitioners don't
use them because they're relatively tricky and
difficult to spit, but that will change as people come
up with better ideas and better mousetraps.
A tongue retaining device that was
explained earlier moves the tongue bodily forward and
forces nasal breathing in most cases. That is not
true with some of the other designs. They are less
effective than mandibular repositioners. And all
studies done on their efficacy back in the 1980s with
Ros Cartwright looked at also changing weight and
position of sleep. Therefore, they never studied the
TRD all by itself, nor did they break those out.
Again, short‑term side effects and
long‑term side effects. It's going to cause excessive
salivation, irrigation on the tip of the tongue from
the suction. Simple. You teach the patient not to
put quite so much suction on the tip of their tongue.
Irritation from the edge of the appliance, wherever it
hits in the mouth, if it hits the Stenson's duct,
where patients have salivary flow or down in the
underneath of their tongue, you're going to get scar
buildup, that appliance needs to be reshaped or
Tongue lengthening. People never thought
of this. I only picked it up because one of my
patients is Hispanic and she is a Spanish teacher.
After three years of using her tongue retaining
device, she could no longer speak Spanish. She
couldn't roll her R's. She had to go into speech
therapy for two months to be able to go back to work.
She's still wearing her tongue retaining device, and
it's three times even longer than that. Now it's got
52 millimeters. But with speech therapy, she can take
care of that.
So if you put suction on soft tissue, it's
going to move. Her teeth have also extruded in the
past because the position that these appliances keep
the anterior teeth open, it means that if there is not
complete coverage of those teeth in back holding them
in position, they are going to move.
Every patient of mine who goes into a
tongue retaining device for more than six weeks
because it takes at least that long before they can
even learn to tolerate it gets retainers. And since
this patient has been in retainers, the last two years
her teeth have not moved, but her bite is still
permanently there. It is probably that that change
came from the fluid buildup in the joint because once
you move the patient, open the anderum sizably, more
than a centimeter, there is going to be fluid buildup
in the joint.
So how do I use all of this to help me
decide what patient I am going to treat and what
appliance. I am going to do the typical looking at
decayed, missing, and filled. Do I have enough teeth
to hold onto the appliance? The forces these
appliances put on teeth are phenomenal and their
periodontal status. I don't want to be doing
extractions. That is a job for an oral surgeon. That
is basically straightforward dental evaluation.
This is the evaluation that really makes
a difference as to how I am going to choose oral
appliance choice. When I am going to look, I am going
to look at the oropharyngeal opening. Is it wide
open? I want that patient. Is it looking like this?
I want them to go see a surgeon first. If it looks
like this, they're getting a tongue retaining device
because I can't see anything back there. I may as
well get that tongue that's as big as Cleveland out of
the way. If I see this, I am going to make sure that
that is not consistently what they are doing before I
send them back to their physician.
When I look at their anterior open bite,
I want to know how these teeth are because the more I
open that anterior segment, the more likely it is that
I am going to rotate that condyle out of the fossal.
If their bite is like this, I have to open
them 11 millimeters to get them past their front teeth
in the first place. Then I have to have room for the
appliance or I'm going to be rotating that condyle way
out of the fossal, and I'm going to end up with a
little bit more problem.
The catch is with the anterior open bites,
those patients, every time you put a millimeter of
material between their molars, it corresponds to a
three‑millimeter opening in the anterior. So if I am
putting in a boil and bite appliance on that patient
that is going to open the posterior six millimeters,
I'm going to be opening them about 18 in front, going
to get into a lot of trouble. So, again, I need to
know where their teeth are because I can decide which
appliance I am going to use.
I want to look at tooth damage. This
patient is a severe gastroesophageal reflex patient
because of his sleep apnea, lo and behold. And when
he is sleeping at night, that acid comes up in his
mouth, eats his teeth away. And his teeth are so
short, the appliance doesn't hold on. He's in a
tongue retaining device at this point.
This patient was sent right off to the
maxillofacial surgeon because I wasn't going to put an
appliance in a mouth that looked like that when she is
in the full bite. This patient is a severe bruxer.
He's been eating his teeth away for years. He breaks
his appliance routinely, about on a monthly basis. I
finally taught him how to realign his own tap in this
case, and he has been happy ever since.
This patient has periodontal problems,
missing teeth. Put that patient in a tongue
Patients I don't touch. I don't touch
this patient. This is a hypoplastic maxilla. I am
moving the mandible forward against the maxilla as my
anchor. If the maxilla is too far back, it doesn't
matter how far I move that mandible. It's not going
to be far enough. Don't treat steep mandibular jaws.
This patient up here doesn't look it
because she doesn't have your typical long lower face.
She has a 50‑degree angle on her mandible. So that
any appliance I put in her mouth will automatically
rotate her mandible almost directly back. And I will
simply lower and exacerbate her blockage.
Patients that are in cross‑bite, either
unilateral or bilateral, where I've got a jaw size
discrepancy, I will do my best to bring those patients
forward, but it would be really nice if their palates
could be split because if the palate is narrow, the
nasal passages are narrow, and I really like to have
free nasal breathing with my appliances.
So for a mandibular repositioning device,
I want to treat retrognathic patients. If they come
in looking like Prince Charles with his money, that
would be nice. Thin patients, young patients. The
older the patient is, you get over 65, appliances
don't work as well. When you're sagging on the
outside, you're sagging on the inside. It's really
hard to get the appliances to work.
Female patients, Marklund, new study shows
an odds ratio of over 12 for just being female with
the success of an oral appliance. I want a healthy
dentition. I want a protrusive range of more than
seven millimeters. And I would like to have a
moderate anterior overbite, which their teeth do
With a tongue retaining device, again, the
correlates with success are normal weight, that they
are worse in a supine position, ‑‑ therefore, they get
better if you put them in a lateral position ‑‑
macroglossia, definitely not tongue‑tied, and normal
soft palate length.
Going to fail with obesity. Retrognathic
patients do not do well with tongue retaining devices
because the real problem is jaw size, short lingual
frenum, tongue‑tied, severe sleep apnea, no positional
changes. And, no matter what, it's less effective
than a mandibular repositioner.
So selection of the appliance depends on
the patient's dental health, on their jaw size, the
severity of disease, age, and lifestyle because I'm
not going to give somebody an appliance that looks
really clunky if that person is really worried about
his Saturday night date.
Looking at occlusal schemes, I am looking
at their bruxism and whether they have acid reflex.
TMJ history, it turns out I have very little problem
with patients who have a history of TMJ. I always
give it to people who have never had it before. The
people who had it before seem to get better.
Mandibular repositioners are one of the number one
appliances used for treating locked jaws.
So fabrication requires that I measure how
much advancement can I get with a George gauge. I
like using adjustable appliances to limit the amount
of joint problems I am going to have. If I take an
impression, I always worry about aspiration of that
material. I want complete coverage of the dentition
and have an impression that doesn't distort, doesn't
have bubbles, or voids. With a tongue retaining
device, I'll do anything to prevent tooth extrusion.
George gauges are fitted in the mouth,
like this, so the teeth come all the way together.
They do have a bite for top and bottom. The patient
can pull his mandible all the way back without tooth
contact, push it all the way out. And on this handle,
here is a millimeter scale that will give you about 18
vectors of movement all put into one nice little
package. It's not as accurate as we would like, but
it's great. It's all we've got.
And then a bite registration is taken at
the position where I think they are not going to get
TMJ pain, which is if they come in with preexisting
TMJ problems, I put them 50 percent forward.
Otherwise it's 60 percent.
So when patients are treating themselves,
first of all, they're not going to have an idea what
kind of periodontal condition that they have because
they don't go to the dentist anyway when they have got
problems. And now with all of this big push on
periodontal disease causing heart disease, you don't
see a huge influx of patients into the office saying,
"Stop my heart disease. I need my gums cleaned."
You have all of the parafunctions that
patients are not aware of. Clenching really bugs me
more than anything else. Bruxism you can see.
Clenching is strictly by report. I look at the
occlusal clasp, the proper fit of the appliance, their
denial of side effects, just as they deny they have
obstructive sleep apnea. All appliances do the same
thing. There has never been any study that shows that
one is less damaging than any others. It is
unpredictable who is going to have problems with tooth
movement when and how far.
One thing we have noticed is that
pregnancy makes it worse, that I've had patients where
there was no jaw repositioning, no tooth movement, and
they got pregnant. When joints start letting go, they
let go. And within two months, she had moved over a
So, in conclusion, there is no way to
predict who will be successful with oral appliances.
Statistics run just about 62 percent of unselected
patients who are successful patients who get worse are
the ones with steep mandibular angles, patients who
gain weight during study times.
We can't predict all of the people who
actually do get worse. There is no way to predict who
will have unwanted side effects. Patients are not
aware of these dental changes. The patients with
symptom relief may still have serious disease. And
there are very few diseases maintaining written
publishable data banks. Alan Lowe does because he is
university‑based. He says 75 percent of his patients
have dental changes at 5 years.
Glenn Clark used to be at UCLA, is now at
USC. He says 50 percent at 5 years. However, Alan's
work is clinical. He actually sees the patient. This
was by questionnaire. So knowing that patients don't
notice that they have dental changes, it could be very
Christ Robertson did not look at the
number. He simply looked at overall statistics. And
Marie Marklund is starting putting together all of her
5‑year data now on over 800 patients.
CHAIRPERSON GULYA: Thank you very much.
Do any of the panelists have any questions? Yes?
DR. STERN: While I understand that there
are a lot of dental changes, how serious are these
dental changes as far as the repercussions other than
cosmetic repercussion, as in facial appearance doesn't
look so good and the bite is not so good? How serious
would that be to the patient if they come in and they
have these changes? Does it really affect them other
than, you know, appearance‑wise?
DR. DEMKO: Right. Basically what I look
for with patients is the patient I showed you with the
great morbidity, where his mandible came forward, he
is a physician. When he disappeared, wore his
appliance, kind of jerry‑rigged it himself for five
years, when he came back and he looked like this and
I really went through the ceiling because dentists
worry in microns, not in millimeters, he looked at me,
and he said, "I'm a physician. The side effects of
what I do kill patients. All you did was move my
jaw." For him, who was a severe sleep apneic and it
totally controlled his disease, he was willing to put
up with that.
What I try to do with patients is the
minute I see something changing where I think it's
going to be permanent, I sit down and talk to the
patient and try to get them to go back on CPAP. If
they refuse, then I always send a letter to their
dentist saying that "This patient's occlusion is
changing." I have never had a patient complain of
anything other than cosmetic changes. They don't have
any difficulty with function. They manage just fine,
just as do edentulous patients who don't wear
CHAIRPERSON GULYA: Okay. Dr. Suzuki?
MEMBER SUZUKI: Jon Suzuki, Dental. Have
you ever had to resort to either major or minor
occlusal adjustment involving enamoplasty when the
teeth migrate or super‑erupt? You didn't mention
DR. DEMKO: I actually send them back to
their own dentist. Because all I do is sleep
dentistry, I don't want any general dentist thinking
that I am stepping on his toes. So I will send them
back, explaining what I think should be done. But I
don't do that. I will send them to the orthodontist.
I will send them back to a general dentist.
But yes, enamoplasty is very important,
especially when you have got a super eruption, mild
super eruption, of molars. That's what's locking them
in place if I can get rid of that.
One of the things I do with oral
appliances is when the anterior teeth start moving,
you can actually put dots of acrylic. Maxillary teeth
tend to labiovert. Mandibular teeth lingualize. You
can put dots of plastic and push the teeth back into
position using an appliance that is thick enough, you
can use it as an orthodontic appliance, put the teeth
back. You just can't if they start splitting out.
CHAIRPERSON GULYA: Okay. Dr. Terris?
DR. TERRIS: Gail, I enjoyed your
presentation. It was very informative. One thing I
hope you can clarify for me, I would have thought that
in terms of the safety of the appliances, one could
make the argument, "Well, the patient can self‑treat."
And if they're having some of these problems, they can
just stop or seek help.
It sounded like from what you said that
some of the changes that can start while they're
self‑treating can become permanent essentially. Is
DR. DEMKO: Right. It's between 6 and 12
months is where we start seeing changes that will
DR. TERRIS: Thanks. Okay.
CHAIRPERSON GULYA: Dr. Zuniga?
MEMBER ZUNIGA: John Zuniga. Do you have
any MRI data to collaborate or support the theory that
there is, in fact, edema in the temporomandibular
DR. DEMKO: The only study done was
published by Fernanda de Almeida. That was published
two years ago. She looked at only eight patients.
They were looking at how far out of the fossa was the
appliance moving them related to the kind of pain and
compliance of that patient. She did pick up that
there was some proliferation of posterior fibers.
There was definite edema. But that was the only
change they picked up.
There are no studies that I know of done
long‑term, certainly not published, looking at MRI
data as to whether we get changes, permanent changes,
in the socket, in the joint.
CHAIRPERSON GULYA: All right. Dr. Li?
DR. LI: Gail, a couple of issues. One,
can you comment on the difference in terms of
retention of the appliance between the boil and bite
type versus a custom type? That's the first question.
The second question is in terms of objective testing
after the delivery of the appliance and on follow‑up?
DR. DEMKO: Okay. The boil and bites are
very rarely as retentive as the custom fabricated
because the custom fabricated locks into better
positioning. Boil and bites when they're heated up,
you bite down into them. They don't come back in and
hug the neck of the tooth. So you're not going to
have a lot of undercut and retention there.
The other appliances, then they're custom
fabricated. You can put clips on them, clasps. You
have other ways of making additional retention on
those. And there's a lot that even I get back from
the laboratory and have to paint on more plastic to
lock in, especially on bruxors or people who have lost
over 20 percent of their tooth bite. So that
retention is very different between boil and bites and
the custom fabricated.
As for objective testing, I will do
preliminary testing using something like a SleepStrip
or an oximeter on a patient to make sure that the
appliance is titrated out to where that says
everything is fine. Then they go back for full
polysome because it's hard to try and get patients to
do that. They don't want to go through another sleep
I will not give them the results of the
test for my Better SleepStrip or whatever, but
routinely I'm finding that they're not far enough
forward. I just had a patient come back with a
SleepStrip of 3, which means he's having more than 25
events an hour. If anything, that is probably under
recording. I want that patient to move his appliance
further forward and go back for full polysome.
CHAIRPERSON GULYA: I think this will be
the last question before we start deliberating.
MEMBER ZUNIGA: Thank you. John Zuniga
once again. What is the cost difference between the
boil and bite and the hard acrylic process?
DR. DEMKO: Do you mean my cost or ‑‑
MEMBER ZUNIGA: General.
DR. DEMKO: ‑‑ or the patient is going to
be doing this? The lab fees run up to, maximum is,
$600 that I have seen for lab fees. That is for the
silencer, the boil and bites. They can get them from
England for $30.
MEMBER ZUNIGA: And the patient who cannot
afford the larger cost, will you use the boil and
bite? Do you have any personal outcomes that you can
share with us?
DR. DEMKO: I very rarely use boil and
bites because they are so bulky and so poorly
retentive that patients do not stay with them. They
will if they get it fit right, if they are very lucky.
But because of arch sizes, where some patients have
extremely wide arches and others don't, the boil and
bites don't fit everybody. It's very hard to find
them. Unless you're looking at a white female, small
white male, it's hard to find boil and bites to fit.
CHAIRPERSON GULYA: Okay. Well, I would
like to thank Dr. Terris and Dr. Demko for some highly
illuminating presentations. They certainly brought
into focus some of the issues and also complemented
the materials provided by FDA staff.
CHAIRPERSON GULYA: According to my math,
which is always suspect, ‑‑ so I am willing to stand
and listen to corrections ‑‑ I think we have about 75
minutes now to start going through some of these
And I am reminded a little bit of the
labors of Hercules. I will remember to thank the FDA
for giving us such a nice task to keep us busy.
That having been said, in all seriousness,
I would like to see us try and tackle question number
1. I think looking at it at one big clump, it seems
insurmountable. But I think if we break it down to
the little bits, we can kind of chip away at it. And
hopefully if we chip away at it, we might even get it
done by lunch, by 12:30.
What I propose we do is in a roundtable
fashion so that every panel member has an opportunity
to speak his or her mind, I would like to go through
each device and have each panelist discuss their
risk‑benefit analysis with respect to the different
So, for example, for the tongue retaining
device, if we could just go through the risks and
benefits of snoring and then through the different
stages of obstructive sleep apnea.
And I think if we keep in mind that we
probably have about 10‑15 minutes for each device and
note that probably some devices will require a little
bit more time, some devices probably a little bit less
time, I think we can kind of in our own heads kind of
adjust how much verbiage we give to each one of these.
So let me see now. Why don't we start
with Mr. Crompton.
MR. CROMPTON: Yes. This is Mike
Crompton. I'm going to limit my discussion to the ENT
devices and then defer to my colleague here for the
I think based on the presentations we
heard this morning, the risk profile for the ENT
devices is obviously less of an issue compared to the
dental devices. However, the definitional aspects are
something that I think I need clarification on and
industry as well in terms of these classifications for
obstructive sleep apnea, primarily the differentiation
between moderate and severe. So we would look to the
panel, the clinicians here, to offer some guidance on
Also, we are going to defer and wait for
Dr. Mann's presentation on the mandibular support
devices, which he alluded to he was going to discuss
that because that, frankly, could be a device that
could be of some value OTC for the OSA indication as
So I think those are the general comments
we have on the devices at this point.
CHAIRPERSON GULYA: Okay. It sounds like
your name was called.
DR. MANN: I just wanted to point out that
we are not going to have any further discussions of
the mandibular support devices, that we just brought
that up because we have received queries from industry
as to what would be necessary in terms of clinical
data to support an indication for obstructive sleep
apnea or snoring with those devices. We have not
received any 510(k)'s for those to date, but based on
the queries, we thought it was reasonable to at least
raise it as a possible device that we may be seeing at
some point in the future.
MR. CROMPTON: Okay. That clarified that,
CHAIRPERSON GULYA: Okay. Thank you. Mr.
MR. SCHECHTER: This is Dan Schechter. I
had some consultations with various members of
industry. The comments that I have received are
somewhat mixed, but I think I would encourage the
panel to consider if there are perhaps a subset of
these devices, even within one of these three dental
device categories that would be suitable for OTC use.
I think it is probably generally
recognized that there are devices, professional
devices, that simply are too complex or too active in
terms of their activity in the mouth to be used over
the counter. But, on the other hand, there are
devices that might lend themselves more easily to OTC
use. I would encourage the panel to try and find that
subset here today.
CHAIRPERSON GULYA: Let's just try and
look at the tongue retaining device in terms of the
risk‑benefit analysis for snoring and obstructive
sleep apnea. I think we can just focus on that for
now and maybe just pass if you feel you do not wish to
comment on that. Ms. Howe?
MS. HOWE: I appreciate the opportunity to
represent consumers to both the Dental and the ENT
Panels and hope that in reviewing the tongue retaining
device and other devices, that we look at the safety
and the efficacy but also access to care, that we're
talking about a large group of people if we do look at
snoring, a large population, who will not readily go
to their dentist or their medical professional for
treatment. And they're seeking some form of treatment
resolution to their problem and also some education
I would like to refer back to the
individual who spoke about the opportunity that an
over‑the‑counter product might give people to learn
more about what is snoring and, in fact, help in the
screening process of OSA.
In referring to one product or the other,
I certainly have to defer to the specialists here, who
can talk more about the manufacturers' products that
they're using or placement, fit, and adjustment
abilities for an over‑the‑counter product. But,
again, hopefully everybody will take into
consideration access to care for people who would not
normally be going to see a professional for their
CHAIRPERSON GULYA: Thank you.
DR. STERN: I'm sorry. Could you please
CHAIRPERSON GULYA: Sure. We're looking
at the tongue retaining device, question number 1,
looking at the risks versus the benefits of allowing
it to be marketed as a device for snoring, obstructive
sleep apnea. What are your thoughts?
DR. STERN: That's a tough question, I
think, because it seems like it has to be a product
that has to be fit a certain way. Consumers have to
be educated regarding putting their tongue in and
retaining it and the side effects and things like
As far as snoring, we need to make sure
that there are some sort of screens that tell me,
"Okay. I'm snoring" and then have a partner or
somebody that is going to be able to listen to what is
going on, a family member. You need another person
involved somehow or a tape‑recording device to find
out exactly what is going on, "Why am I having this
problem?" It seems like it's a multifactorial thing
It seems to me also that the lack of
public awareness is a significant issue with regard to
this. Even myself as a physician, I was not aware
that this was something that would be an option to
recommend to patients.
So I think lack of public awareness is a
significant issue here. And I am not convinced that
if there is something that is going to be made over
the counter, then are there enough documented studies?
It seems like most of these things have a
fairly small number of patients. And so if it is
going to be made over the counter, I would recommend
that it probably be recommended that it be tried over
the counter and then see what studies have been done
to show that this is a modifiable appliance that can
be even used and that patients are able to understand
the impact and the significance and the indication for
being able to be used and that it is understood that
this is recommended only for snoring and maybe not for
obstructive sleep apnea and that the risks and the
benefits and alternatives are also explained in lay
language and whether or not this would be a product
that would be easy to use. It's just something you
just put it in your mouth and then stick your tongue
in here. And this is what you do, and it's used for
a certain amount of time. Is this something that's
going to be easy to use, easy to adjust? And I'm not
sure that I am convinced that that is the case yet at
CHAIRPERSON GULYA: Thank you very much.
MEMBER ZERO: Domenick Zero, Dental
Products Panel. I will give a qualified response in
that I am not an expert in this area, and I am
learning a lot about it. It is a very fascinating
This may apply to all of these devices
that are under consideration. The first issue is
diagnosis. I don't understand how a patient or an
individual can make an appropriate diagnosis as to the
condition they have, the severity of that condition,
and then following from that the appropriate treatment
decisions to manage that condition. I just don't. In
something as complicated as this and something as
serious as this, I don't see how an individual can
make that decision from an over‑the‑counter product.
The other issue is monitoring. It is
obvious that there are a number of untoward effects
that can occur that can be at least controlled and
modified if a professional is involved, a dental
professional is involved with that use of the device.
I don't see how an individual can properly monitor the
symptoms, the changes that could occur in their mouth
over time and do that in a way that would prevent a
So with that, I see the risk‑benefit to be
really on the side of too much risk and not enough
CHAIRPERSON GULYA: Thank you very much.
DR. LI: I concur in terms of the
diagnosis. I see approximately 30 new sleep patients
a week. And I perform sleep studies on all of them.
Even for well‑trained physicians in terms of
specializing sleep, I'm often surprised at the
severity of the disease with their objective testing.
So I think it would be in error to approve
an OTC device that "treats" sleep apnea without a
physician evaluation and to really look into the
severity of the problem. That's number one.
In terms of a tongue retaining device, my
understanding of the literature is that the result is
actually fairly mixed. And that goes along with some
other devices as well. So in terms of efficacy, I
think before even approving that as an OTC device, we
will have to look at the effectiveness of the device.
CHAIRPERSON GULYA: Could you please
address the issue of snoring? I just heard about OSA.
DR. LI: I think in terms of, well, the
first issue, I think for the layman, you need to
separate the issue between snoring and sleep apnea.
In terms of snoring, I think it's reasonable for a
tongue retaining device to probably be approved for
snoring, but in terms of fabrication, the
effectiveness, I think it would be a pretty
challenging issue for the manufacturer to make it
effective for snoring improvement.
CHAIRPERSON GULYA: Okay. Thank you.
MEMBER JENKINS: I would think in terms of
snoring that the risk‑benefit ratio would be better in
that it can control that and if the changes in
dentition are monitored, then it could possibly be,
you know, that caveat needs to be into labeling that
they need to have monitoring and possible changes in
However, in obstructive sleep apnea, since
we as physicians have trouble making this diagnosis,
to have a patient make this diagnosis and use it as an
across‑the‑counter device on their own, that I think
would be very difficult. And the risk‑benefit ratio
would be very negative.
CHAIRPERSON GULYA: Thank you.
MEMBER SUZUKI: Jon Suzuki, Dental
Products. I guess one of my major questions would be
if the tongue retaining devices were, in fact, OTC,
would it increase at all the risk for either
aspiration or partial obstruction of airway? I don't
believe I have heard data representing either side.
CHAIRPERSON GULYA: From my read of the
literature we were provided, I would have concerns of
providing this as an OTC device, certainly for the
OSA, for reasons that have been already suggested in
terms of the difficulty of even us making diagnoses
with sophisticated equipment.
For snoring, again, I am not convinced
that there is data showing sufficient efficacy. So
that would be I would have concerns on all fronts
regarding the tongue retaining device.
MEMBER ZUNIGA: John Zuniga. I'm coming
from the point of view of that of a person with
clinical experience with patients, but from listening
to what has been presented here ‑‑
EXECUTIVE SECRETARY S. THORNTON: Excuse
me, Dr. Zuniga. Could you please speak into the
microphone a little bit more?
MEMBER ZUNIGA: I'm sorry. From reviewing
what I have heard today and the provided information,
I think it is quite clear that the tongue devices for
OSA do not provide the benefit versus the risks that
it can ensue. And, similarly for snoring, the
information is minimal for efficacy. So I think that
for both cases, the risks are higher than the
CHAIRPERSON GULYA: Thank you.
DR. MAIR: Eric Mair, San Antonio. In
typical vice presidential debate fashion, I think I
want to answer one other question first from the
DR. MAIR: The question was, what is the
difference ‑‑ I mean, this is important ‑‑ between
mild, moderate, and severe apnea and how that effects
because we really need to know what those definitions
The AASM has come out with these
definitions. And mild is between 5 to 15 apnea or
hypopnea events per hour. Moderate is 15 to 30. And
severe is greater than 30. It's important to know
those are more than just numbers. There's no adequate
prospective study that has validated the severity
criteria for any of this. And the reason for the
severity criteria is based on some data from the
Wisconsin Sleep Cohort that showed an increased risk
of hypertension with an AHI of approximately 30.
So to distinguish mild to moderate apnea
is a very difficult thing to do. And it's not based
on really good science. To throw another wrench into
everything, too, we talk about ‑‑ in all of the
studies that we have presented so far today have
mentioned that the gold standard is the polysomnogram.
We do everything based on the polysomnogram. I think
that we know now that the gold standard is a little
Some of the studies that we have been
doing and many others have been doing, too, have
looked at the variance of reader to reader of
polysomnogram and the night‑to‑night variation. These
can be greater than 30 percent in multiple studies,
What this means is that one question asked
I think by John is, what happens if someone has severe
apnea? Can they have mild apnea afterwards? I think
David's answer was only after some sort of therapy,
not necessarily so. It's so dependent on the study
itself, where it's done, how it's read. There are
some problems in this area.
Back to the question at hand, tongue
retaining devices I strongly feel should not be over
the counter, mostly for reasons that there are
different manufacturers of these, that for the patient
to squeeze the tongue and give negative pressure on
the tongue so that there's going to be venous
congestion of that area, we're concerned about airway
edema, airway problems if these things intermittently
fall off in the middle of the night if there is too
much negative pressure on these things. They could
cause some significant tongue edema, which from a
surgeon's point of view, from ENT, that's one of the
problems that we deal with. We could see this
definitely over the counter. And just on tongue we're
talking about right now.
Let me pass it on to the next vice
CHAIRPERSON GULYA: Dr. Orloff?
DR. ORLOFF: Thank you. Lisa Orloff.
Just sort of an extension of what you just said, Eric,
if there is such variation in the interpretation of
polysomnography or variation from one night to the
next, I guess we have to look at whether our follow‑up
polysomnograms after treatment are really reflecting
an improvement or a lack of improvement adequately
with any of these devices.
Specifically addressing the tongue
retaining device and snoring, not sleep apnea but
snoring, from what I have heard today and from what I
have read, I have gotten the impression that the
tongue retaining device is the least favorable oral
appliance relative to the mandibular repositioning
device. And I'm not sure about comparison directly
with the palatal lifting device.
My fear if the tongue retaining device
were to be over‑the‑counter ‑‑ and I think we'll be
discussing the other devices more next ‑‑ are likely
to not be supported for obstructive sleep apnea use by
this panel, that more patients would be selecting the
one product that is available over‑the‑counter, being
the tongue retaining device, when it is actually
appropriate for what sounds like the smallest subset
of patients with snoring. So I would oppose having it
be available over the counter.
CHAIRPERSON GULYA: Thank you.
DR. WOODSON: Yes. Gayle Woodson. I'm
pretty much in concurrence with everybody who has
talked so far in terms of what is the best thing in
terms of an ideal world where everybody can go to the
doctor and get their sleep study and know these
I think we live in a world where not
everybody in the country has health insurance. Even
those who have health insurance, many times their
health insurance doesn't cover the cost of a sleep
study or maybe it will pay for it if you get the sleep
study and it turns out you have sleep apnea, it will
pay for the study, but if not, it's out of your own
pocket. So there are definite economic things we have
to think about.
So when we treat patients, even in our
office, with snoring, sometimes we go ahead and treat
snoring because there are not the resources to do the
sleep apnea testing.
So if you think about that the major risk
of a lot of these snoring treatments is that 25
percent of them could have sleep apnea, well, that may
be just a ‑‑ otherwise, if we're dooming everybody to
continue suffering with snoring without trying
anything else, if we deny all snoring treatments
because they should have sleep testing, I don't think
I have enough evidence in here to tell me whether
tongue retaining devices help snoring. I think there
are some patients that it probably would work with and
some that it wouldn't.
I think, rather than saying a blanket "No,
no tongue retaining device should be over the counter"
or "Yes, they all should," I think that they would
have to be on an individual basis of looking at the
data for each device and having real clear labeling,
telling people if somebody knows you stop breathing,
although with the labeling, the warnings, the caveats.
I think we have to be careful about
blocking people from being able to try something that
doesn't have a lot of down side risk from the
CHAIRPERSON GULYA: Dr. Terris?
DR. TERRIS: In response to Eric Mair's
comments, I was going to suggest that I could be Dick
Cheney and maybe you would be John Edwards when, in
fact, it doesn't work because we totally agree.
And so your criticism of polysomnography
is one of my favorite topics to talk about. I didn't
discuss that in my 12‑minute presentation that I was
allocated this morning, but yes, the so‑called gold
standard is the best