Someone shopping for an over-the-counter (OTC) hearing aid may have to sort through dozens of products, determine which ones are regulated by the FDA, figure out what insurance will cover, and find an expert willing to help choose and set up a device.
A new JAMA Viewpoint by UC San Francisco researchers says these hurdles show why making hearing aids available without a prescription, while an important step, has not been enough to ensure people can find and use the devices they need.
“Over-the-counter hearing aids have opened the door for many people who might otherwise never have gotten hearing aids,” said Kathryn A. Phillips , PhD, a UCSF professor of health economics and health services research. “But people still have to figure out what to buy, whether they can afford it, and where to get help.”
The U.S. Food and Drug Administration created the OTC category in 2022 for adults with perceived mild-to-moderate hearing loss, allowing them to buy hearing aids without a prescription or professional fitting.
The change has substantially lowered costs. OTC hearing aids are about $500 on average, compared with $3,400 for prescription devices, according to data cited by the authors. Among people buying hearing aids for the first time, 70% chose an OTC device.
But Phillips and co-author Christine K. Cassel, MD, found major obstacles remain.
Products vary widely in price, features, and ease of use, and consumers may have trouble determining whether a device is a regulated hearing aid. One study cited in the article found that only about one-quarter of Amazon listings marketed as OTC hearing aids could be verified as FDA cleared or registered.
Expert help can be hard to find, too. One in 5 OTC hearing-aid users reported receiving no professional assistance, while just 51% received the full range of services that can include evaluation, device selection, and fitting. Audiology practices have long bundled these services with prescription hearing aids, an approach that does not easily accommodate people who buy devices on their own.
Insurance adds another hurdle. Traditional Medicare does not cover hearing aids, and coverage varies among Medicare Advantage, Medicaid, and commercial insurance plans. Even plans that offer coverage may have requirements designed around prescription devices such as having to use certain vendors.
A policy breakthrough and what came next
Cassel, a UCSF professor of medicine and expert in geriatrics and health policy, helped lay the groundwork for making hearing aids available over the counter. She co-chaired a hearing-loss working group for the President's Council of Advisors on Science and Technology, whose work helped inform the federal policy that led to the FDA rule.
“Making hearing aids available over the counter removed an important barrier, and that was a major advance,” Cassel said. “Now we need trustworthy information, professional help when people want it, and coverage policies that reflect the way hearing aids are sold today.”
For Phillips, the remaining gaps became clear when she developed hearing loss and entered the OTC market herself.
After struggling to find professional guidance, Phillips spent more than $2,000 on OTC hearing aids and months working with customer service to adjust them. Then the parent company of the brand she had purchased stopped servicing the devices in the U.S.
Her experience helped prompt her to examine the broader evidence on how well the new system was working.
“I study how new technologies move into health care and what policies help people benefit from them, and suddenly I was experiencing those questions myself,” Phillips said. “I realized that if I was having this much trouble navigating the system, other people were probably struggling, too.”
Making access work in practice
Phillips and Cassel suggest several ways to make the system easier to navigate. Consumers could receive copies of their audiograms and hearing-aid programming information, much as they can take an eyeglass prescription to the provider of their choice. Audiologists could offer stand-alone consultations to people who buy OTC devices, and insurers that cover hearing aids could explicitly include OTC products in their plans.
The authors also call for better data on who uses the devices, what people pay, how well the devices work across diverse populations, and how they affect audiology services and health care delivery. Future legislation that expands hearing aid coverage should account for OTC devices as well.
The lessons may extend beyond hearing care, Phillips said, as regulators consider moving other medical products from prescription to over-the-counter status.
“Changing a regulation can create access, but it doesn't automatically create a system that people can navigate,” she said. “If we want these changes to improve people's health, we have to pay attention to what happens after the product reaches the shelf.”
Authors: Kathryn A. Phillips, PhD, and Christine K. Cassel, MD, of UCSF.
Funding: The work was supported by the National Human Genome Research Institute (R01-HG011792).
Disclosures: Phillips reported receiving personal fees from the Institute for Clinical and Economic Review evidence review committee and previously consulting for Illumina, Roche, and Danaher outside the submitted work. No other disclosures were reported.
About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health , which serves as UCSF’s primary academic medical system, includes highly-ranked specialty hospitals and other clinical programs, and has affiliations throughout the Bay Area. UCSF School of Medicine also has a regional campus in Fresno. Learn more at ucsf.edu .
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Commentary/editorial
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Over-the-Counter Hearing Aids 4 Years Later
15-Oct-2026
Phillips reported receiving personal fees from the Institute for Clinical and Economic Review evidence review committee and previously consulting for Illumina, Roche, and Danaher outside the submitted work. No other disclosures were reported.