SOURCE: Hearing Industries Association


March 27, 2017 12:00 ET

Hearing Industries Association (HIA) Response to the Over-the-Counter Hearing Aid Act of 2017

WASHINGTON, DC--(Marketwired - March 27, 2017) - On March 20, 2017 the Over-the-Counter Hearing Aid Act of 2017 (S.670) was introduced by Senators Elizabeth Warren (D-Mass.), Charles Grassley (R-Iowa), Maggie Hassan (D-N.H.) and Johnny Isakson (R-Ga.). The bill would require the Food and Drug Administration (FDA) to propose a rule to establish an over-the-counter hearing aid (OTC) category for adults with "perceived" mild to moderate hearing loss within three years of passage of the legislation. Representatives Joseph Kennedy III (D-Mass.) and Marsha Blackburn (R-Tenn.) have introduced an Over-the-Counter Hearing Aid bill (H.R. 1652) in the House, which mirrors the Senate bill.

Hearing Industries Association (HIA) supports efforts to increase accessibility and affordability of hearing aids. Nearly two thirds of people with hearing loss in the U.S. have a mild hearing loss, and only 10 percent of them currently do anything to address that loss. If the FDA creates an OTC hearing aid category, the devices should be high-quality and only offered to people with mild hearing loss, for whom the benefits of amplification clearly outweigh the risks that are created by possible inaccurate self-diagnosis and self-directed treatment. The legislation as introduced would encourage people with moderate hearing loss to also attempt self-directed treatment, where the risks of failure and further delay in treatment are significantly greater. HIA does not condone a do-it-yourself approach to diagnosing hearing loss.

"The hearing industry is innovating at a more rapid pace than ever before with new advancements such as signal processing for hearing in noise, directional hearing, and Bluetooth connectivity. There is confusion among today's consumer with the introduction of Personal Sound Amplification Products (PSAPs), OTC hearing aids and other 'smart' devices," said HIA Chairman Brandon Sawalich. "Designed for a self-directed approach, OTC devices would not be able to match the long-term health benefits, convenience, personalization or features of professionally fit hearing aids -- they would not be customized to an individual's unique needs. Proper diagnosis and selection of hearing aids require the skill of educated and trained hearing healthcare professionals, which includes screening, diagnostic testing, product solution, fittings, adjustments, counseling, maintenance and aftercare. The average patient will need to be seen multiple times over the life of the hearing aid, which is why patient satisfaction with their hearing aids is at an all-time high of over 90 percent. Personalized hearing healthcare makes the difference, which is even more critical as a person addresses greater levels of hearing loss, including moderate loss."

Almost 40 million people reported as part of the National Health Interview Survey that they or someone in their household has a hearing problem. However, Better Hearing Institute (BHI) research confirms that people wait four years on average before acknowledging a hearing problem and consider seeking help. When someone finally takes action, it is important that they take effective action using a quality device. To increase the likelihood that OTC hearing devices would be safe and effective for people with hearing loss, HIA also believes that FDA should require that all OTC hearing devices meet the same safety and efficacy standards that FDA requires of air-conduction hearing aids fitted by hearing health professionals. The use of an inferior or inadequate device could put them at an increased risk of the serious medical conditions associated with untreated hearing loss. HIA also believes it is crucial that FDA review and finalize its 2013 draft PSAP Guidance document to clarify that unregulated PSAPs cannot be marketed to address hearing loss.

HIA has offered perfecting language to strengthen patient safeguards and improve the accessibility of hearing aids while ensuring that high quality, safety and efficacy standards are upheld, and HIA will continue to work with Congress to ensure that such safeguards are included in the legislation.

About HIA

HIA, headquartered in Washington, DC, is the national trade association of manufacturers of hearing aids, implantable hearing devices, assistive listening devices, component parts and power sources for amplification devices. For more than 40 years, the HIA-funded Better Hearing Institute (BHI) has worked tirelessly to increase public awareness of the importance of hearing health and treating hearing loss. For decades HIA, through BHI, has been conducting research and educational outreach so people with hearing loss can benefit from proper treatment.

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    Andy Bopp