> January 14, 2004

Dockets Management Branch

> Food and Drug Administration
>
> 5630 Fishers Lane, Room 1061, HFA-305
>
> Rockville, MD 20852
>
> Subject: Comments on Citizen's Petitions to FDA
>
> The American Academy of Otolaryngology-Head and Neck Surgery formally
> comments and expresses concern regarding the Citizen's Petitions filed
> with the FDA by Killion and Gudmundsen. Our opposition to the
> citizen's petitions is based on issues regarding patient safety and
> health.
>
> The Killion petition \[2003P-0362\] proposes a new device to amplify
> sound for the hearing impaired. While the petition proposes to make
> sound louder for individuals and the device cheaper than current
> hearing aids, it actually raises patient safety concerns because the
> device could amplify sound to 115dB Sound Pressure Level -- fully 25
> decibels above the "safe level" for individual's noise exposure. The
> paradox presented here is that a device proposed to aid consumers with
> impaired hearing could damage and diminish the normal or residual
> hearing of an individual user, leaving them with impaired hearing! In
> our currently noisy world, the addition of another source of acoustic
> trauma is neither safe nor healthy.
>
> The Gudmundsen petition \[2003P-0363\] fails to offer full disclosure
> to consumers, de-emphasizes (if not underestimates) the medical nature
> of hearing loss, and potentially delays appropriate medical treatment
> when indicated.

Currently, *Code of Federal Regulations, Title 21, Volume 8. Cite:
21CFR801.420 Subpart H - - Special Requirements for Specific Devices,
Section 801.420 Hearing aid devices: professional and patient labeling,
and Section 801.421 Hearing aid devices: conditions for sale*, sensibly
and appropriately requires hearing aid dispensers to obtain a medical
waiver from adults who are purchasing a hearing aid. Revocation of
*Subpart H Section 801.421* as requested by the petitioner is a threat
to patient safety.

The current waiver informs consumers with examples of medical/surgical
conditions that represent a threat to citizens' safety and health. The
aptly named "red warning flags of ear disease"(draining ears, sudden
onset of hearing loss and or dizziness, a "bad" ear versus a normal
hearing ear, recent physical trauma, etc. -- all readily apparent to the
individual or their parents) should be evaluated by a physician,
preferably a specialist in ear, nose and throat diseases. Specialized
radiographic and clinical laboratory tests may be indicated to diagnose
surgically and medically treatable diseases such as cholesteatoma and
autoimmune sensorineural hearing loss. Recent advances in the successful
medical and surgical treatment of hearing nerve impairments make the
option of medical evaluation evermore relevant. Consumers should be
offered this opportunity for a medical diagnosis before they chose a
prosthetic device and perhaps ignore a potentially life-threatening
medical/surgical condition. Thus citizens retain free choice and
responsibility for their health but only after being appropriately
informed.

Your careful consideration of our concerns is appreciated. A personal
contact is offered through the offices of our Executive Vice-President,
David R. Nielsen, MD, at 703-519-1559.

Respectfully submitted,

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David R. Nielsen, MD

Executive Vice President

American Academy of Otolaryngology---

Head and Neck Surgery