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U.S. Department of Health and Human Services

Advisory Committees

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December 18, 2009: Ear, Nose, and Throat Devices Panel Meeting Announcement

Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee
of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Ear, Nose, and Throat Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and recommendations 

to the agency on FDA’s regulatory issues. Date and Time: The meeting will be
held on December 18, 2009, from 8 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.
Contact Person: James K. Kane, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 301–796–6477, or FDA Advisory Committee Information Line, 1–800–
741–8138 (301–443–0572 in the Washington, DC area), code
3014512522. Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore, you
should always check the agency’s Web site and call the appropriate advisory
committee hot line/phone line to learn about possible modifications before
coming to the meeting.

Agenda: On December 18, 2009, the committee will discuss, make
recommendations, and vote on a premarket approval application,
sponsored by Envoy Medical Corporation, for the Esteem Totally
Implantable Hearing System. The ESTEEM is a totally implantable hearing
device that is implanted in the middle ear to help hearing in patients suffering
from mild to severe hearing loss that is sensorineural in origin. The Esteem
System consists of three implantable components (Sound Processor, Sensor,
and Driver), two external programmers (Esteem Programmer and Personal
Programmer), an external Intraoperative System Analyzer (ISA) and accessories.
The intended use of the ESTEEM is to alleviate hearing loss in adults by
replicating the ossicular chain and providing additional gain.
FDA intends to make background material available to the public no later
than 2 business days before the meeting. If FDA is unable to post the background
material on its Web site prior to the meeting, the background material will
be made publicly available at the location of the advisory committee
meeting, and the background material will be posted on FDA’s Web site after
the meeting. Background material is available at http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.

Procedure: Interested persons may present data, information, or views,
orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before December 8, 2009.
Oral presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make formal oral presentations should notify
the contact person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 30, 2009. Time
allotted for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to determine
the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak by
December 1, 2009.

Persons attending FDA’s advisory committee meetings are advised that the
agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with physical
disabilities or special needs. If you require special accommodations due to
a disability, please contact AnnMarie Williams, 301–796–5966 or
annmarie.williams@fda.hhs.gov by December 4, 2009.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/ucm111462.htm for procedures on
public conduct during advisory committee meetings. Notice of this meeting is given under
the Federal Advisory Committee Act (5U.S.C. app. 2).
Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26260 Filed 10–30–09; 8:45 am]