The Food and Drug Administration moved Tuesday to make hearing aids available over the counter and without a prescription to adults, a long-awaited request by consumers frustrated by expensive exams and equipment.
As soon as mid-October, people with mild to moderate hearing loss will be able to buy hearing aids online and in stores, without having to see a doctor to get a prescription to get a prescription.
The FDA cited studies that estimate that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and turn it into a wider field of less expensive and perhaps more innovative designs. Current costs for hearing aids, which tend to include a visit to an audiologist, range from about $1[ads1],400 at Costco to about $4,700 elsewhere.
“This could fundamentally change technology,” said Nicholas Reed, an audiologist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies can come up with. We can literally see new ways hearing aids work, what they look like.”
The FDA’s final rule takes effect in 60 days. Industry representatives say device makers are mostly ready to launch new products, although some may need time to update labeling and packaging or to comply with technical details of the rule.
Dr. Robert Califf, the FDA Commissioner, tweeted Tuesday that the rule tackles a “critical public health problem” affecting millions.
“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to a range of safe, effective and affordable hearing aids from their neighborhood store or online,” he said.
Hearing loss is associated with cognitive impairment, depression, isolation and other health problems in older adults. Still, barriers to getting hearing care have included costs not covered by Medicare. There is also stigma – such as appearing “old” – that comes with use.
Understanding of the importance of sharp hearing for adults is also inappropriate: A recent survey found that people aged 50 to 80 were twice as likely to plan to take their pet to the vet in the coming year than to have their hearing checked .
“It breaks my heart a little bit,” said Sarah Sydlowski, assistant director of improvement at the Cleveland Clinic Head and Neck Institute and lead author of the study. “I think our biggest challenge as a profession and as a healthcare system is to make sure people understand that hearing is incredibly important. It deserves your attention, it deserves your action.”
The change has been going on for years. In 2016, a proposal to the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss came in a report from the National Academies. The following year, Senators Chuck Grassley, a Republican from Iowa, and Elizabeth Warren, a Democrat from Massachusetts, introduced a bill allowing the agency to make the change that was signed into law.
The process to finalize the regulations has been slow since then, with some conflicts over details, such as how the federal rule would interact with state laws on hearing aid returns or warranty rules and how much the devices should amplify sound.
President Biden issued an executive order last July calling for greater competition in the economy, which included a call for the rule “to promote the broad availability of affordable hearing aids” to be published.
That rule came out this fall, followed by a period of public comment. The Hearing Industries Association, an industry group, submitted a 45-page comment letter warning the FDA about companies that had entered the market in 2018, after the original law was passed, and were selling hearing aids that “were ineffective, of poor quality and in some cases, dangerous.” The organization gave detailed advice on how to avoid a repeat scenario.
“We applaud the action to increase access to care for people who are struggling and encourage them to seek a professional,” to help navigate their options and the adjustment process, said Kate Carr, president of the trade group. Other organizations raised concerns that the FDA would create a safety issue by allowing new hearing aid manufacturers to create devices that allow users to hear loud sounds.
Senators Warren and Grassley had released a joint report accusing “dominant” hearing aid manufacturers of engaging in an “astroturf lobbying” effort by inundating the FDA with repeated comments steering the agency toward a new generation of hearing aids that would be ” less efficient, protect manufacturers’ existing market share and lock in their competitive advantage.”
“The logic is simple: The less effective an OTC hearing aid is, the more likely consumers will be forced to abandon these options and instead opt for more expensive prescription devices sold by the manufacturers that dominate this industry,” the senators’ investigation says. said the report.
The FDA reviewed more than 1,000 submitted comments on the rule and made a handful of changes in the final version released Tuesday. They include lowering the maximum sound output of the devices and revising the ear canal insertion depth limit. The rule also requires that the hearing aids have a user-adjustable volume control and simplified wording on the product label.