Over-the-Counter Hearing Aids FDA Considers Two Citizen’s Petitions Policy Analysis
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Policy Analysis  |   November 01, 2003
Over-the-Counter Hearing Aids
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Regulatory, Legislative & Advocacy / Policy Analysis
Policy Analysis   |   November 01, 2003
Over-the-Counter Hearing Aids
The ASHA Leader, November 2003, Vol. 8, 1-19. doi:10.1044/leader.PA.08212003.1
The ASHA Leader, November 2003, Vol. 8, 1-19. doi:10.1044/leader.PA.08212003.1
Joe would like to wear hearing aids occasionally, for watching TV or to hear his grandchildren clearly again. He goes to the pharmacy and purchases a hearing aid for less than $150—without a medical exam or a visit to an audiologist.
This scenario would become reality if the U.S. Food and Drug Administration (FDA) acts on citizen’s petitions filed by Mead Killion and Gail Gudmundsen that would eliminate the requirement for a medical evaluation or waiver and create a class of over-the-counter (OTC) hearing aids.
“Both of our petitions were filed to urge changes in federal regulations that would ease entry into the world of hearing aids,” said Gail Gudmundsen. “We arrived at our conclusions after much debate and discussion.”
Gudmundsen and Killion bring more than 60 years of experience to audiology during which they’ve made numerous contributions to the profession. Killion is president of Etymotic Research in Elk Grove Village, IL, where he holds 40 patents and is author or co-author of several inventions, such as the K-AMP high fidelity amplifier. Gudmundsen, who is president of Gudhear, Inc. in Elk Grove Village, has been fitting hearing aids for 30 years and now works primarily at Etymotic Research. She also serves as chair of the Illinois State Speech-Language Pathology and Audiology Licensure Board.
Gudmundsen’s petition, which was filed with the FDA on August 8, would eliminate the federal regulations that restrict the sale of hearing aids to adults unless they have obtained a medical evaluation of their hearing loss within six months, or have signed a waiver. Instead Gudmundsen proposes that the user instructional brochure inform consumers that a hearing aid will not restore normal hearing, prevent progressive hearing loss, or improve the underlying causes of organic hearing loss. The proposed language would also inform consumers that some types of hearing loss can be medically corrected, and provide eight indicators for conditions that should be medically evaluated.
Regulations requiring children with hearing loss to receive a medical evaluation and treatment by a physician and audiologist would remain the same.
For many years ASHA has advocated for removal of the waiver for adults both to the FDA and at congressional hearings, said Susan Brannen, ASHA’s vice president for professional practices in audiology. A 1994 statement issued by ASHA stated, “Neither a medical evaluation nor warning signs are necessary components of the pre-purchase hearing evaluation if the comprehensive audiological assessment is conducted by an audiologist.”
Killion’s petition, filed August 7, asks the FDA to create a classification for one-size-fits-most hearing aids that could be sold over-the-counter. The device would have a peak output of 115 dB or less to provide a margin of safety from high-intensity sounds, and would cost an estimated $40 to $300, according to the petition.
This petition raises many complex and critical issues, Brannen said. “Certainly its intent to bring to millions of consumers amplification to improve their quality of life is laudable,” she said. “But it’s terribly important not to underestimate the value of the audiologic rehabilitation that allows a person with hearing loss to have success with a hearing aid. Fitting a hearing aid requires that we treat the person and their particular needs—not an audiogram. The petition appears to undermine the need for aural rehabilitation.”
Cost Barrier
According to Killion’s petition, the cost of hearing aids is a major barrier for consumers who would like to try amplification—and largely the result of current FDA policy. “It is well-documented that our present system works for the 20% of people with hearing loss that see a professional,” he said, adding that the other 80% who say they need hearing aids don’t get them. Of these, 30% say they can’t afford the hearing aids on the market, and 50% don’t get hearing aids for other reasons, including a reluctance to see a professional, Killion said.
Drawing on the “overworked, but pertinent” comparison between hearing aids and reading glasses, Killion noted that it costs a consumer with mild hearing loss $1,500 to $6,000 or more to purchase binaural hearing aids, while the same consumer with a mild visual impairment can purchase binocular reading glasses in retail outlets for $10 to $20. “Those who suffer the worst effect of the present FDA hearing aid policy are seniors on a fixed income,” Killion said in the petition.
The operative principle that separates OTC drugs or devices from those that require prescription is whether misuse can cause harm, Gudmundsen noted in her petition. “The potential harm from direct purchase of a hearing aid without medical evaluation is negligible.”
In the end, the retail sale of reading glasses may provide a prediction for OTC sale of hearing aids. In the vision care industry, Killion noted in the petition, the majority of eyeglasses are dispensed professionally, even though low-cost reading glasses are readily available in retail outlets.
“We believe the proposals in our petitions have the potential to help the profession of audiology by bringing many more people into the system,” Gudmundsen said. “Nonetheless, the important issue is whether or not the proposed changes will benefit those with hearing loss—not whether it benefits us as audiologists. I believe that audiologists will never be replaced by OTC hearing aids, inexperienced practitioners, or medical personnel, because audiologists are uniquely qualified to provide diagnostic testing and rehabilitative services.”
FDA Response
According to FDA regulations, the agency has six months to respond to a citizen’s petition in notifying the petitioner that the petition is accepted or rejected, or additional time is needed for consideration. Comments may also be filed in support or opposition of a petition at any time. Action on the petitions in changing regulations regarding hearing aids would also require a proposed rule and comment in the Federal Register.
“The petitions are under review and agency consideration at this time. FDA is very interested in public comment regarding this issue. We look forward to hearing from all interested parties and value their viewpoints,” said Teri Cygnarowicz, a scientific reviewer and audiologist with the FDA.
Comments can be submitted to: Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061 (HFA-305), Rockville, MD 20852; e-mail fdadockets@oc.fda.gov; phone 301-827-6860.
For more information about the petitions, contact Ingrida Lusis through the Action Center at 800-498-2071, ext. 4482 or by e-mail at ilusis@asha.org.
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November 2003
Volume 8, Issue 21