Five years after the Over-the-Counter Hearing Aid Act of 2017 was passed, the Food and Drug Administration finalized the historic rule on Tuesday. The Act creates a new class of lower-cost hearing aids designed for mild-to-moderate hearing loss. OTC hearing aids can be purchased directly from stores, pharmacies and online retailers with no prescription or medical evaluation required. Products are expected to hit shelves in mid-October.
Implementation of the new guidelines was accelerated in July 2021 when President Biden issued a wide-ranging executive order to promote more competition and called on the FDA to finalize action on over-the-counter hearing aids within 120 days. A preliminary report was released last October, and last month, a bipartisan investigative report, “Loud and Clear,” also helped to spur finalization of regulations.
While some industry experts say OTC hearing aids might be priced as low as $600, consumers should expect to pay about $1,400 per individual aid.
The cost of hearing aids is not covered by Medicare although most private Medicare Advantage plans do. Only about half of state Medicaid programs cover the devices, but benefits in those states vary widely. Prescription hearing aids (which are categorized as an FDA class 1 medical device) can range from $1,600 to $8,000.
“Right now, five multinational companies control more than 90% of the global marketplace for hearing aids. It’s a low-volume, high-margin market where the audiologist is the gatekeeper,” said Dr. Frank Lin, MD, PhD, director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health. “But when manufacturers can sell directly to the retail market, it fundamentally changes the business model. In the end, the regulations follow the exact spirit of the truly bipartisan bill, which is to drive access, affordability, competition and innovation. The FDA has set clear guideposts, but it’s not overly restrictive.”
What can consumers expect?
In the Tuesday briefing, FDA Commissioner Dr. Robert Califf, MD, said the agency is working with manufacturers to ensure new devices meet the agency’s performance criteria. Consumers will be helped by labeling requirements, and health guidelines were also developed, including a list of hearing loss symptoms that should prompt a consultation with a specialist.
“The idea that the FDA is finally enacting legislation passed five years ago is exciting because it solves a public health problem through market-shaping strategy,” said Lin. “The FDA got the regulations right in the sense there is a clear path for companies like Apple, Samsung and Bose to enter the hearing aid market. There’s increasingly a convergence between consumer electronic and health care devices. Apple’s a perfect example: An Apple Watch can monitor atrial fibrillation—so is it consumer tech or a health device? The new regulations allow convergence to happen on a much faster scale.”
OTC hearing aids won’t change things for people with greater than moderate hearing loss, so those patients will still need a licensed health care professional for prescription aids. While the OTC market will clear the path for millions of new users, they could potentially lead to inadequate testing and further hearing loss.
But Michelle Arnold, an audiologist and assistant professor at the University of South Florida, said there’s no evidence consumers will be harmed buying a hearing aid without seeing an audiologist, and the benefits of getting some improvement in their hearing outweigh risks.
More choices but also confusion for consumers
With the entry of big tech companies, new OTC brands offered by established hearing aid companies, and new players into the market, customers will have lots of options—which can lead to confusion.
“It will become challenging for customers to make purchasing decisions,” said Phillip Orso, audiologist and founder of Makehear.
Hearing loss is individualized, with problems linked to different environments or specific frequencies. Those with hearing loss cannot accurately diagnose whether impairment is mild, moderate or greater, caused by a medical issue or something easily treated, like ear wax.
So while OTCs are designed to work out-of-the-box (and are required to have a volume control for self-adjustment), consumers shouldn’t bypass hearing specialists, Orso said.
“Seeing an ear, nose and throat specialist is recommended in the FDA guidelines to exclude persons with red flag signs like sudden hearing loss,” he said. “Although the new aids will be easy to use, some people – especially older adults – might need assistance.”
OTCs will feature a variety of options that will be reflected in pricing. At the lower end, basic OTCs will feature nonadjustable frequency programs and volume control. More advanced OTCs will offer rechargeable batteries, Bluetooth, and smartphone apps to adjust programs and volume, and will be priced accordingly.
“Consumers will need to test two or three devices to find the best brand for their needs, and the FDA’s final rule does require manufacturers to clearly state return policies,” Orso said.
Consumers considering an OTC should ask questions to determine which brand will be the best choice to improve their hearing.
Changing landscape for established companies and hearing care professionals
“Sonova (Phonak and Unitron), ReSound, Oticon or Signia own the existing technology, have marketing budgets and established provider networks in place,” Orso said. “Companies offering easy integration – like Apple’s iPhone and dedicated OTC apps – those with good customer support, and companies providing training for their retail and hearing provider partners will benefit most and emerge as market leaders.”
“Some hearing professionals are already unbundling services and pricing to serve the OTC model including training customers on use, cleaning and changing consumables (like silicone ear domes) for a fee,” he added. “The rest of the professional hearing care sector is expected to unbundle services, but it may take a while for them to do that.”
Path forward for caregivers
So, how often does hearing loss factor into the daily lives of caregivers? Hearing aid treatment can ease caregiver stress and provides many health benefits to seniors, such as delaying onset of dementia, depression and preventing falls.
“It would be a smart move if caregivers gain essential knowledge of OTC hearing aids,” said Orso. “They should know the basics like inserting and removing OTCs from the ear, changing and charging batteries, cleaning filters and replacing ear domes. These services are easy to learn and essential for those who use OTCs.”