FDA clears the way for over-the-counter hearing aids

The Food and Drug Administration (FDA) moved today to make hearing aids available over the counter and over the counter for adults, a long-awaited desire of consumers frustrated by expensive tests and devices.

As early as mid-October, consumers with mild-to-moderate hearing loss should be able to buy over-the-counter hearing aids online and in retail stores, without needing to see a doctor for an exam to get a prescription.

The FDA cited studies that estimate that about 30 million Americans experience hearing loss, but only one-fifth of them receive help. The changes could shift the market, which is dominated by a relatively small number of manufacturers, into a larger field with less expensive and perhaps more innovative designs. Current costs for hearing aids, which tend to include visits to an audiologist, range from around $1,400 at Costco to about $4,700 elsewhere.

“This could fundamentally change the 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 will happen to these companies. We can literally see new ways hearing aids work, how they look.”

The FDA’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details of the rule.

Dr. Robert Califf, FDA Commissioner, tweeted Tuesday that the rule addresses a “critical public health issue” that affects millions.

“Establishing this new regulatory category will allow people with mild to moderate perceived hearing loss to have convenient access to a variety of safe, effective and affordable hearing aids at their neighborhood store or online,” he said.

Hearing loss is associated with cognitive decline, depression, isolation, and other health problems in older adults. However, barriers to hearing aids include costs not covered by Medicare. There is also the stigma, such as looking “old,” that comes with use.

Appreciation of the importance of acute hearing for adults is also misplaced: 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 next year than to get a hearing test.

“It breaks my heart a bit,” said Sarah Sydlowski, associate director for enhancement 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 health care system is making sure people understand that hearing is incredibly important. It deserves your attention, it deserves your action.”

Change has been seeping in for years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss was published in a report by 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 became law.

The process to finalize the regulations has moved slowly since then, with some conflicting over details, such as how the federal rule would interact with state laws on return of hearing aids or warranty policies and how much the devices should amplify sound.

President Biden issued an executive order last July calling for more competition in the economy, which included a call for the rule to be published “to promote the wide availability of low-cost hearing aids.”

That rule came out in the fall, followed by a public comment period. The Hearing Industries Association, an industry group, sent a 45-page comment letter warning the FDA about companies that had entered the market in 2018, after the initial law was passed, selling hearing aids that “were ineffective.” , of poor quality and in poor condition”. some cases, dangerous.” The organization offered detailed advice on how to avoid a repeat of the scenario.

“We applaud action to increase access to care for people who are struggling and encourage them to seek out a professional” to help them navigate their options and the adjustment process, said Kate Carr, president of the trade group. Other organizations expressed concern that the FDA would be creating a safety problem by allowing new hearing aid manufacturers to make devices that allow users to hear loud sounds.

Senators Warren and Grassley released a joint report accusing “dominant hearing aid” makers of engaging in an “artificial turf lobbying” effort by inundating the FDA with boilerplate comments leading the agency toward a new generation of hearing aids that they would be “less effective in protecting manufacturers’ existing market share and securing their competitive advantage.”

The logic is simple: the less effective an over-the-counter hearing aid is, the more likely it is that consumers will be forced to abandon these options and instead opt for more expensive prescription devices sold by the manufacturers that dominate this line of business. said the senators’ investigation. report said.

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