• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

Ear, Nose, And Throat Devices Panel - July 20-21, 2000

DIVISION UPDATE
Nancy C. Brogdon – Acting Director

Ms. Brogdon notified the public and panel that the Division Director, Dr. Ralph Rosenthal is temporarily working in the Center Director’s Office working on issues related to the Health Care Financing Administration (HCFA). She introduced the new Director of the Office of Evaluation, Dr. Bernard Statland. She noted that Mr. Harry Sauberman, Chief of the Ear, Nose and Throat Devices Branch was working elsewhere in the Office on special projects including partnering with other countries’ governments. Dr. Morris Waxler was introduced as the Acting Branch Chief for Mr. Sauberman. She also introduced Dr. James K. Kane, a new audiologist with the Ear, Nose and Throat Devices Branch. 

Plaques were presented by Ms. Brogdon to Voting Members whose term expires in October, 2000. The panel members so honored on July 20, 2000 were: 

Dr. Gayle Woodson – Dr. Woodson was a consultant to the panel beginning in Sept. 1994. In Nov. 1996 she was converted to a voting member. Her perspective as a laryngologist has been important to the panel, and her input on hearing aids, cochlear implants and labeling has been invaluable.

Dr. William Duffell – Dr. Duffell has been the Industry Representative on the panel since March,1997. He has been proactive, open and approachable. He is also active in medical device industry groups who are partnering with various parts of FDA on different projects, so the Agency will continue to benefit from his participation.

On July 21, 2000 a plaque was presented to Dr. Clough Shelton – Dr. Shelton has been a voting member of the panel since Nov. 1996. As an otologist active in teaching and surgery, his perspective has been important in the panel’s deliberations, for example in discussion of a middle ear implant guidance

BRANCH UPDATE
Morris Waxler, Ph.D. – Acting Branch Chief

  • FDA has developed a partnership with Health Canada for the review of premarket approval applications (PMAs) and investigational device exemption (IDE) submissions for ENT devices. Two of the colleagues from Health Canada are present at today’s meeting as observers: Fred Lapner, M.D. and Daliang Wang, M.D., Ph.D.
  • Introduction of Staff

The staff of the Ear, Nose and Throat Branch includes:
Karen Baker, RN – Scientific Reviewer, registered nurse
Teri Cygnarowicz, MA, CCC-A, FAAA – Scientific Reviewer, audiologist 
Sidney Jaffee, M.D. – Medical Officer
James Kane, Ph.D., CCC-A – Scientific Reviewer, audiologist
Vasant Malshet, Ph.D. – Scientific Reviewer, toxicologist
Alfred Montgomery, D.V.M. – Senior Regulatory Reviewer

Our staff is supplemented as needed with reviews from other components of CDRH, e.g. Brian Beard, Ph.D. and Bill Regnault, Ph.D. for engineering; Victor Krauthamer, Ph.D. for neurophysiology; statisticians; and others. Thanks for the team efforts.

  • Workload summary
The Ear, Nose and Throat Branch reviewed 307 applications last year. Two-thirds of these applications were investigational device exemptions (IDEs). The remaining one-third was about equally divided between premarket applications (PMAs) and pre-market notifications (510ks). In addition, the Branch worked on standards for various devices.

PMA PRESENTATION – JULY 20, 2000

PMA P990052 – SYMPHONIX, Inc. 

The Vibrant Soundbridge System® is a direct-drive, implantable middle ear hearing device intended for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. The Vibrant Soundbridge consists of two main subsystems: 1) the implant called the Vibrating Ossicular Prosthesis or VORP; and 2) the external amplification system called the Audio Processor.

Panel Recommendation by vote: Approvable with Conditions 7-0 (unanimous)

The conditions of approval:

The intended use statement for the device should be revised to state:

  • The Vibrant Soundbridge is indicated for use in adults, 18 years of age and older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.

Specifically identified claims proposed by the sponsor should be revised to state:

  • For most subjects the Vibrant Soundbridge does not significantly affect residual hearing for most subjects; however, a small % experienced residual hearing loss.
  • Based upon subjective responses, the Vibrant Soundbridge significantly improves clarity and overall sound quality compared to hearing aids.
  • Patients report that the Vibrant Soundbridge provides better overall fit and comfort compared to conventional hearing aids.
  • Vibrant Soundbridge patients perceived significant benefit in many listening situations, such as, familiar talkers, ease of communication, reverberation, reduced cues, background noise, aversiveness of sound, and distortion of sound.
  • Speech perception test results in a controlled soundfield environment (e.g., NU-6 word scores, SPIN-low predictability word scores) did not demonstrate a significant mean change in scores between the Vibrant Soundbridge and the hearing aid. However, when listening to speech the Vibrant Soundbridge was preferred over the presurgery hearing aid in various listening situations.
  • The Vibrant Soundbridge provides significant improvement in word recognition in the presence of background noise compared to the unaided condition and is equivalent to the conventional hearing aid condition.

The claim that the Vibrant Soundbridge significantly improves a patient’s satisfaction and perceived benefit in challenging listening environments for many patients should be removed.

Other revisions to the labeling were, the addition of a statement that the safety and effectiveness of bilateral implantation has not been established and a statement that the possibility of facial nerve paralysis and taste disturbance exists

Lastly, the panel included the condition that the subjects be followed for device extrusion during a postmarket follow-up period.

PMA PRESENTATION – JULY 21, 2000

PMA P000015 – COCHLEAR CORPORATION 

The Nucleus 24 Auditory Brainstem Implant (ABI) System is intended to restore useful hearing to individuals 12 years of age or older with Neurofibromatosis Type II (NF2), who become deaf as a result of surgery to remove bilateral auditory nerve tumors.

Panel Recommendation by vote: Approvable with Conditions 9-0 (unanimous)

The conditions of approval:

  • Labeling

The therapeutic claim in the package insert should be revised to state, "Of the 90 subjects implanted, 82% perceived sound when stimulated."

The Clinical Study Results Section should also include the percent of subjects who perceived sound.

The sponsor should add the percent of subjects who perceived hearing when stimulated to all claims and simplify all the claims by eliminating all fractions and "by chance" percentages.

The labeling should include the statement that, "The efficacy of bilateral functioning implant has not been studied."

The sponsor should amplify the information in the surgeon’s manual on neurophysiologic monitoring.

A statement should be added stating that extreme caution should be observed in considering implantation for patients who have undergone gamma knife radiation because of possible injury to the cochlear nucleus.

  • Additionally,

The device should be delivered without the magnet in place and with the appropriate modifications of directions in the surgeon’s guide.

The panel strongly recommended that implanting team should receive training in the techniques used for appropriate implantation.

CLOSING ANNOUNCEMENTS 

The meeting tentatively scheduled for September 22, 2000 has been cancelled. The meeting schedule for 2001 will be available on the web within the next two months.

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov 

Transcripts May Be Purchased From:
(Written Request Only)
Neal R. Gross & company
1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005
(202) 234-4433

OR

Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax) 

*Executive Summary May Be Purchased From:
(Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 82706500 (voice) (301) 443-1726 (fax) 

*Under normal conditions, panel summary minutes are available 60-90 days post