The scale of the access problem that motivated the policy change is hard to overstate. Hearing loss affects a large share of older adults, yet hearing aids have historically been among the least adopted medical devices in the country, priced out of reach for many and gated behind a professional infrastructure that audiologists had effectively monopolized. The FDA’s rule changed that calculus dramatically. Over-the-counter devices now average about 500 dollars, according to data cited by the authors, compared with roughly 3,400 dollars for prescription hearing aids. That price collapse has had a visible effect on the market: among people buying hearing aids for the first time, 70 percent now choose an over-the-counter device rather than a prescription one.

Phillips, a professor of health economics and health services research at UCSF, frames the achievement in measured terms. Over-the-counter hearing aids have opened the door for many people who might otherwise never have gotten hearing aids, she notes, but people still have to figure out what to buy, whether they can afford it, and where to get help. That three-part burden, she and Cassel argue, is where the new system shows its cracks. The regulation created a product category; it did not create the surrounding ecosystem of information, service, and coverage that determines whether a device sitting on a shelf actually improves someone’s hearing and quality of life.

The first crack is informational. The over-the-counter market is crowded with dozens of products that vary widely in price, features, and ease of use, and consumers have no reliable way to distinguish a regulated medical device from an unregulated amplifier. The distinction matters: devices marketed as hearing aids that have not been cleared or registered with the FDA may not meet safety and effectiveness standards, yet listings on major retail platforms rarely make the regulatory status clear. One study cited in the JAMA Viewpoint found that only about one-quarter of Amazon listings marketed as over-the-counter hearing aids could be verified as FDA cleared or registered. For a shopper trying to make a medically consequential purchase on their own, that is a sobering statistic.

The second crack is professional support. The FDA’s framework was designed for adults with perceived mild-to-moderate loss, a population that policymakers assumed could self-diagnose and self-fit with the help of smartphone apps and adjustable presets. But hearing care is not a purely technical exercise. Evaluation, device selection, and fitting form a bundle of services that audiology practices have long packaged together with prescription hearing aids, and that bundled model does not easily accommodate people who buy devices on their own. The numbers cited by Phillips and Cassel are striking: one in five over-the-counter hearing-aid users reported receiving no professional assistance at all, while only 51 percent received the full range of services that can make the difference between a device that sits in a drawer and one that is actually worn.

Insurance is the third crack, and arguably the most stubborn. Traditional Medicare does not cover hearing aids, a gap that predates the over-the-counter category but now interacts with it in confusing ways. Coverage varies across Medicare Advantage, Medicaid, and commercial insurance plans, and even plans that do offer a benefit may impose requirements designed around prescription devices, such as restricting reimbursement to certain vendors. A consumer who buys a 500-dollar device at a pharmacy may discover that their plan would have contributed to a prescription model but cannot accommodate an over-the-counter purchase, or that navigating the benefit costs more time than the device is worth. The financing system, in other words, has not caught up to the retail one.

Cassel brings an unusual perspective to the critique, because she helped build the system she is now evaluating. 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. She remains convinced the reform was a major advance: making hearing aids available over the counter removed an important barrier, she says. But her prescription for the next phase is pointed. What is needed now, she argues, is trustworthy information, professional help for people who want it, and coverage policies that reflect the way hearing aids are actually sold today rather than the way they were sold a decade ago.

For Phillips, the remaining gaps are not abstract. She developed hearing loss herself and entered the over-the-counter market as a consumer, an experience that reshaped her research agenda. After struggling to find professional guidance, she spent more than 2,000 dollars on over-the-counter 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 United States, leaving her with expensive hardware and no support pathway. As someone who studies how new technologies move into health care and what policies help people benefit from them, she found herself living the questions she had long analyzed. Her conclusion was blunt: if she was having this much trouble navigating the system, other people were probably struggling too.

The Viewpoint does not simply diagnose the problem; it sketches a reform agenda. Phillips and Cassel propose that consumers receive copies of their audiograms and hearing-aid programming information, much as patients can take an eyeglass prescription to any provider they choose, which would make device ownership portable across brands and service providers. They call on audiologists to offer stand-alone consultations for people who buy over-the-counter devices, decoupling professional expertise from device sales. Insurers that cover hearing aids, they argue, should explicitly include over-the-counter products in their plans, and future legislation that expands hearing aid coverage should account for over-the-counter devices from the start rather than retrofitting a prescription-era benefit.

The authors also press for better data, and this may be the most consequential request of all. Little is systematically known about who uses over-the-counter devices, what people actually pay across the full market, how well the devices perform across diverse populations, and how the shift is reshaping audiology services and health care delivery more broadly. Without that evidence, policymakers are steering by intuition. And the stakes extend well beyond hearing care, Phillips argues, as regulators consider moving other medical products from prescription to over-the-counter status. Changing a regulation can create access, she observes, but it does not automatically create a system that people can navigate. If these reforms are to improve people’s health, the work cannot stop when the product reaches the shelf. The Viewpoint, published in JAMA with Phillips and Cassel as authors and supported by funding from the National Human Genome Research Institute, is essentially a four-year report card on a landmark policy: the door is open, the prices are down, and now the harder work of building a usable system begins.

Subject of Research: Barriers to navigating the over-the-counter hearing aid market four years after FDA deregulation

Article Title: Why it's still hard to get the right over-the-counter hearing aid

Article References: Why it's still hard to get the right over-the-counter hearing aid. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: over-the-counter hearing aids, FDA regulation, hearing loss, audiology, health policy, Medicare, insurance coverage, consumer access, JAMA Viewpoint, UCSF, health economics, medical devices