WASHINGTON, DC — The US Senate passed the FDA Reauthorization Act today. The legislation, as reported previously, contains a provision that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. A House version of the bill was passed last month.
The OTC provision of the legislation would allow for hearing aids to be used “by adults to compensate for mild to moderate hearing impairment” to be sold over the counter. The bill also requests the FDA to issue regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).
Stakeholders React to OTC Legislation Passage
In response to the news of the legislation passing, the American Academy of Audiology (AAA) said that it will remain proactive in ensuring federal policy makers understand the importance of audiologic care.
“With the passage of the OTC legislation, we, as audiologists, must continue to lead through consumer education, outreach to other providers, and partnerships with federal agencies. Our efforts will now shift towards directly engaging with the FDA and FTC to shape new OTC hearing aid device regulations that will be developed and implemented in the coming months and years.”
–Ian Windmill, PhD, AAA President
The American Speech-language Hearing Association (ASHA) put out a statement regarding the bill’s passage in the Senate, and like AAA, suggested the organization will be working directly with the FDA to help develop the regulations for OTC devices:
ASHA advocated to Congress that OTC hearing aids should only be available for perceived mild hearing loss, that output limits must be set, and warnings against use for children. ASHA maintains that the best approach to addressing hearing loss is to seek the professional services of an audiologist and will continue to express its concerns with H.R. 2430 as it works with the FDA to develop regulations for implementation.
The Hearing Loss Association of America (HLAA), which has championed the legislation, hailed the passage of the bill through the Senate.
“For years, our number one request has been from people who want hearing aids but can’t afford them. This legislation is a step in the right direction and offers hope that the cost of all hearing aids will go down with the anticipated market innovation and competition it will bring. Everyone who needs hearing aids should be able to have them to stay connected to family, remain on the job, and enjoy a high quality of life.” –Barbara Kelley, HLAA Executive Director
The Consumer Technology Association (CTA) also expressed its approval of the bill’s passage:
Thanks to bipartisan support on this issue, millions of Americans will improve their quality of life with little impact on their pocketbook. Until now, nearly half of online U.S. adults-98 million Americans-with hearing loss have been unable to access adequate hearing assistance due to prohibitively high hearing aid costs as well as the inconvenience and financial burden of doctors appointments. This legislation will create a new class of over-the-counter hearing aids costing roughly one-tenth the price of traditional hearing aids, making it easier for those with mild-to-moderate hearing loss to afford the hearing assistance that they need. We look forward to President Trump signing this legislation into law.” –Gary Shapiro, CTA President and CEO
What’s Next for OTC Hearing Aids?
Following passage of the Over-the-Counter Hearing Aid Act by both the House and Senate, the bill will head to the president to be signed into law.
Once the bill is signed into law, the FDA will begin drafting rules and regulations for the new OTC category of hearing aids. The FDA has three years to complete the rules and regulations surrounding OTC devices, but advocates and organizations like HLAA are hopeful the process is completed much sooner.
**HHTM has extensively reported on the developments surrounding the Over-The-Counter Hearing Aid Act since it was first introduced. We will continue to bring you the latest news and opinion surrounding the issue of OTC hearing aids, so please stay tuned and visit often for the latest updates!