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regulations containing safety and labeling requirements for the new OTC category of hearing aids, as well as update its draft guidance on Personal Sound Amplification Products (PSAPs).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!
Its not a bad step to help poorer sections of society who need the help right away ! But, we all know that hearing impaired people aid need more than just a cheap hearing aid. They need guidance and expertise that they cannot get at an OTC joint !
Hearing care is healthcare. Many health problems are connected to poor hearing. One should never commoditize healthcare. There are many affordable hearing aids that allow for exact and proper prescriptions. OTC “hearing aids” will never have good sound quality, and will more than likely wind up in a persons dresser drawer rather than in their ears where they belong. OTC amplifiers are a big step in the wrong direction, and those advertising them are confusing and misguiding patients who need proper hearing care. Good hearing healthcare involves both the patient and audiologist working together to come to solutions that are best for the patient.
All it does is muddy the waters and let people who don’t understand the difference between the technologies, delude themselves into thinking they are getting the necessary help, when in fact, they are not. It will become very easy for them to say, “I got a hearing aid. How come I still can’t understand everything? Hearing aids suck, just like all those people have said for so many years.”
But at the same time, because low-end devices now count toward the government’s analysis of hearing aid average selling price, that number will drop, and the statisticians will make the claim that the law did its job by lowering the average cost of hearing aids. Never mind, that the average cost of good quality hearing aids will not drop. In fact, it may go up, because now some of the patient base who would have invested more money in better quality technology will not get confused and opt for the lower quality technology. In order to make up the lost revenue, vendors throughout the supply chain will have to INCREASE prices on good quality custom-fit technology.
Grandma’s hearing horn worked just fine. Hearing aids shouldn’t cost more than a smart phone or a computer, but this technology market has long exploited the cost for this medical need. A cheap device is better than nothing, which is what millions of have! I applaud any legislation that helps the quality of life at an affordable and sensible price
I think the first thing that should be addressed when viewing Hearing Aids, is the outlandish price. When you consider the engineering and parts that go into an iphone; costs< $1,000.00,a decent laptop computer < $1000.00, a med/large TV (not 4K) < $1500.00.
Then you can buy a bottom of the line Hearing aid from a Hearing aid dispenser (retail store) for $2,500+, if you want to upgrade to more programming and a better processor $5000.00+. Does it really cost more to manufacture a Hearing aid than an iphone, a TV, a Laptop etc. The short answer is NO. The Hearing aid industry has set up the pricing, such that the Hearing aid dispensers are guaranteed a substantial profit. Probably to the tune of 100-300%. Of course they spend time fitting you and programming your device. It