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Summary From the Ear, Nose, And Throat Devices Panel Meeting - August 16, 2002

DIVISION UPDATES
David M. Whipple, Deputy Director
Division of Ophthalmic and Ear, Nose and Throat Devices

Mr. Whipple introduced Dr. Eric A. Mann who has joined the Division Staff as the Chief of the Ear, Nose, and Throat Devices Branch since the last panel meeting in July, 2000. He also noted that the Office Director, Dr. Bernard Statland, would be leaving the FDA, thereby vacating his position as Director of the Office of Device Evaluation. His position will be filled by Dr. Daniel Schultz, who is currently the Office Deputy Director of Clinical and Review Policy.

BRANCH UPDATES
Eric A. Mann, M.D., Ph.D., Chief
Ear, Nose and Throat Devices Branch

Introduction of Staff

The staff of the Ear, Nose and Throat Branch includes:

  • Eric A. Mann, M.D., Ph.D. - Branch Chief, Otolaryngologist
  • Karen Baker, RN, MSN – Scientific Reviewer, Expert Nurse Consultant
  • Teri Cygnarowicz, MA, CCC-A, FAAA – Scientific Reviewer, Audiologist
  • Sidney Jaffee, M.D. – Medical Officer
  • James Kane, Ph.D., CCC-A – Scientific Reviewer, Audiologist/Hearing Scientist
  • Vasant Malshet, Ph.D., DABT – Scientific Reviewer, Toxicologist

Product Approvals since previous panel meeting in July, 2000.

  • Implantable Middle Ear Hearing Devices (IMEHD)

    P990052 - Vibrant Soundbridge System (Symphonix Devices, Inc.)
    Approved: 8/31/00

    Intended Use: To provide a useful level of sound perception to individuals via mechanical stimulation of the ossicles

    Indicated: For adults (>=18 yrs) with moderate to severe Sensorineural hearing loss (SNHL) desiring an alternative to acoustic hearing aids. Experience with appropriately fit hearing aids is recommended prior to implantation.

    P010023 - Soundtec® Direct System™ (SOUNDTEC, Inc.)
    Approved: 9/7/01

    Indications for use: For adults (>=18 yrs) with moderate to severe SNHL with a desire for an alternative to acoustic hearing aids. Experience with appropriately fitting hearing aids is recommended prior to implantation.
  • Cochlear Implants

    P000025 - COMBI 40+ Cochlear Implant System (MED-EL Corporation)
    Approved: 8/20/01

    Intended Use: for severe to profoundly hearing-impaired individuals who obtain little or no benefit from conventional acoustic amplification in the best aided condition

    Indicated For:
    Adults (>=18 yrs) with bilateral severe to profound SNHL, pure tone average >= 70 decibels (dB), and limited benefit from hearing aids (HINT scores <= 40% in best aided conditions)

    Pediatrics (18 mos. - 17 yrs, 11 mos.) with bilateral profound SNHL (thresholds >= 90 dB at and above 1000 Hz, with a 3 to 6 month hearing aid trial, and lack of auditory skill development; <20% score on multi-syllabic lexical neighborhood test (MLNT) or the lexical neighborhood test (LNT).

    P000025/Supplement 1- Combi 40+S(compressed) Electrode Array
    Combi 40+GB (split) Electrode Array
    Approved: 7/29/01

    Intended Use: for those severe to profoundly hearing impaired individuals with ossified and/or malformed cochleas; with little or no benefit from conventional acoustic amplification in the best-aided condition.

    P970051/Supplement 15 - Nucleus 24 CI 11+11+2M Double (Cochlear Corporation) 
    Approved: 6/6/02

    Indicated For: patients who have cochlear ossification preventing full insertion of a standard Nucleus 24 cochlear
    implant electrode array.
  • Brain Stem Implant

    P000015 - Nucleus®24 Auditory Brainstem Implant (Cochlear Corporation.)
    Approved: 10/20/00

    Intended Use: to restore useful hearing via electrical stimulation of the cochlear nucleus in the brain stem

    Indicated For: >= 12 yr with Neurofibromatosis Type II. Implantation may occur during first or second side
    tumor removal or in patients with previously removed acoustic tumors bilaterally

  • FDA Statement on Meningitis in Cochlear Implant Patients

    The FDA has become aware of a possible association between cochlear implants and the occurrence of bacterial meningitis. We have received more than 25 reports from the United States and more than 20 reports from abroad of bacterial meningitis associated with cochlear implantation. Cases have occurred in children and adults ranging in age from 21 months to 82 years. The onset of meningitis symptoms has ranged from less than 24 hours to greater than 5 years from time of implant. At least 12 known deaths have resulted from these cases, with 3 of these deaths occurring in the United States. Although most cases have been caused by Streptococcus pneumoniae (pneumococcus), other organisms -- including Hemophilus influenza, enterococcus, Esherikia coli, and Streptococcus viridans -- have been cultured. Most of the patients have been children, predominantly under the age of 5, but some adults with cochlear implants have also developed meningitis.

    The cause of meningitis in these cochlear implant recipients has not been established. A small percentage of deaf patients may have congenital abnormalities of the cochlea (inner ear) which predispose them to meningitis even prior to implantation. Patients who become deaf as a result of meningitis are also at increased risk of subsequent episodes of meningitis compared to the general population. Other predisposing factors may include young age (< 5 years), otitis media, immunodeficiency, or surgical technique. The cochlear implant, because it is a foreign body, may act as a nidus for infection when patients have bacterial illnesses.

    Design of the electrode is also being considered as a possible predisposing factor. The Advanced Bionics CLARION device differs from other currently marketed cochlear implants because it uses an additional piece called “the positioner” which is introduced next to the electrode into the cochlea to facilitate transmission of sound information to the auditory nerve. Advanced Bionics has agreed to discontinue use of the positioner in these countries and will be marketing one of their current cochlear implant systems containing the HiFocus I electrode without the positioner. The company has also initiated a voluntary recall of unimplanted CLARION devices in the United States and has announced that it will be seeking FDA approval for the HiFocus I electrode without the positioner.

    FDA believes that cochlear implant candidates, as well as those already implanted, may benefit from vaccinations against organisms that commonly cause bacterial meningitis, particularly Streptococcus pneumoniae and Haemophilus influenzae. The immunization status should be ascertained for all candidates for cochlear implants prior to surgery as well as for those with an existing implant. We would again refer you to the FDA website on the screen for specific vaccinations recommendations.

    In some of the reported cases of meningitis in cochlear implant recipients, patients may have had overt or sub-clinical otitis media prior to surgery or before the meningitis developed. Physicians are encouraged to consider appropriate prophylactic perioperative antibiotic treatment, and to diagnose and treat otitis media promptly in patients with cochlear implants.
    We encourage you to report cases of meningitis in cochlear implant recipients. You can report these directly to the device manufacturer or you can report them to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch one of four ways: Show slide with contact info….

    A team of experts from the various offices within CDRH has been formed to assess this issue, and we are working closely with the manufacturers and collaborating with our colleagues at the CDC to gather complete information on all cases that have occurred within the U.S. Although FDA is carefully investigating these reported cases of meningitis, we recognize that cochlear implantation has been a highly effective procedure to restore hearing function in over 20000 patients in the US and approximately 60000 patients worldwide. We are currently working with the CDC to investigate ways to better define any risk of meningitis associated with cochlear implantation in this population and to develop measures that can be implemented to reduce any identified risks.


GENERAL ISSUES DISCUSSION

The agenda for the August 16, 2002 open session of the Ear, Nose and Throat Devices Panel Meeting was a discussion of a draft guidance entitled "Implantable Middle Ear Hearing Device; Draft Guidance For Industry and FDA." At the June, 1999 Panel Meeting, the Panel discussed many of the issues that were incorporated into the document; however, at this time we are presenting the draft for further comment and recommendation.

The Panel was asked to focus their discussion on three areas and direct their answers to the following questions:

  • the role of animal studies in determining safety and effectiveness for the implantable middle ear hearing device (IMEHD)

    What is the role of animal studies in the development of an IMEHD? When should preclinical animal studies be performed to support the safety and performance of an IMEHD?

  • additional assessments, if any, related to the clinical protocol for evaluating the IMEHD

    What additional assessments, if any, would you recommend be included in Section 5 (Investigational Device Exemptions) to evaluate the safety and effectiveness of the IMEHD?

    Currently there are several hearing aid fitting algorithms for conventional hearing aids, based on real-ear measurement techniques. These algorithms predict appropriate gain as a function of frequency for various patterns/magnitudes of hearing loss and hearing aid circuitry (e.g., linear vs. compression).

    1. Should IMEHD manufacturers be responsible for developing similar fitting algorithms for their devices?
    2. If so, should there be common units of measurement among different manufacturers?

    What control condition(s) should studies with an IMEHD include? Should it be "state-of-the-art" acoustic hearing aids? If so, how does one define "state-of-the-art" or "optimally fit" if they are to be utilized in the controls? Should the condition include a comparison to the “best aided” condition, including binaural amplification?

    Previous clinical studies with the two approved IMEHDs showed enhanced patient satisfaction with these devices despite the fact that objective hearing assessment results were similar to those using conventional hearing aids. What additional assessments, if any, could be used to demonstrate an enhancement in hearing performance to account for a subjective improvement in patient satisfaction?

  • the common performance characteristics, e.g., output, gain, frequency response, of the IMEHD

    Conventional hearing aid labeling includes performance characteristics based on standardized measurement methodology (i.e., ANSI S3.22, 1996). Given the different types of implantable middle-ear hearing devices (e.g., semi- vs. totally-implantable; electromagnetic vs. piezoelectric), what, if any performance characteristics can be shared among these different device types? What performance characteristics would you want to standardize and include in device labeling (APPENDIX B) common to all IMEHD devices?

NOTE TO THE PUBLIC

The IMEHD draft guidance is up for public comment on the FDA website for a period ending September 12, 2002.

CLOSING ANNOUNCEMENT

The October 17-18, 2002 tentatively scheduled meeting of the Ear, Nose and Throat Devices Meeting has been cancelled. Information on the December 12-13, 2002 meeting will be available by mid-October, 2002.

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053 Ext. 127,
email smt@cdrh.fda.gov

Transcripts can be obtained from: (Written Request Only)
Neal R. Gross & company
1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005
(202) 234-4433 (voice) or
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) 827-6500 (voice) (301) 443-1726 (fax)

*Under normal conditions, panel summary minutes are available 60-90 days post meeting. Please time your requests accordingly.

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