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

The Food and Drug Administration has decided to offer over-the-counter and over-the-counter hearing aids to adults, long desired by consumers frustrated by exams and expensive equipment.

As early as mid-October, people with mild to moderate hearing loss can purchase hearing aids online and in retail stores without having to visit a doctor for a prescription.

The FDA cites studies that estimate that about 30 million Americans have hearing loss, but only about one-fifth of them get help. These changes could transform the market, which is dominated by a relatively small number of manufacturers, and transform it into a broader field with less expensive designs and perhaps More creative. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco arrive about $4,700 in other place.

“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, how they look. “

The FDA’s final rule goes into effect after 60 days. Industry representatives say device manufacturers are largely ready to roll out new products, although some may need time to update labels and packaging or comply with specifications in the industry. Rule.

Dr. Robert Califf, FDA Commissioner, tweeted Third, the rule addresses a “significant public health issue” that affects millions of people.

“Establishment of this new regulatory category will enable people with mild to moderate hearing impairment to conveniently access a wide range of safe, effective and affordable hearing aids,” he said. from your local store or online.

Hearing loss has been linked to cognitive decline, depression, isolation, and other health problems in older adults. However, barriers to getting hearing assistance have included costs not covered by Medicare. There is also the stigma – such as appearing “old” – that comes with use.

Adults also appreciate the importance of keen hearing: Recent survey found that 50 to 80 year olds plan to take their pet to the vet in the next year twice as often as getting their hearing checked.

“It broke my heart a little bit,” said Sarah Sydlowski, associate director of innovation at the Cleveland Clinic’s 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 that people understand that hearing is incredibly important. It deserves their attention, it deserves their action.”

Change has been instilled over the years. In 2016, a proposal for the FDA to approve over-the-counter hearing aids for adults with mild to moderate hearing loss was made in a National Academy. report. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill that would allow the agency to make changes. signed into law.

Since then, the process of finalizing the regulations has been slow, with some inconsistencies in details, such as how the federal rule would interact with state law on returns or equipment warranty policies. hearing aid and its amplification level.

President Biden issued an executive order last July calling for greater competition in the economy, including a call for the rule to “promote the widespread availability of low-cost hearing aids.” to be announced.

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

“We welcome action to increase access to care for those in need and encourage them to seek out a specialist,” said Kate Carr, president of the trade group, to help guide their options. their selection and the right process, said Kate Carr, president of the trade group. Other organizations raised concerns that the FDA would create a safety problem by allowing new hearing aid manufacturers to manufacture devices that allow users to hear loud sounds.

Senators Warren and Grassley Released a joint report accuses “dominant” hearing aid manufacturers of engaging in “space travel lobbying” efforts by flooding the FDA with repeated comments directing the agency toward a new generation of hearing aids will “be less effective, protecting manufacturers’ existing market share and locking in their competitive advantage. “

The logic is simple: The less effective OTC hearing aids are, the more likely consumers are to be forced to forego these options and instead opt for more expensive prescription devices sold by manufacturers. dominate this business,” the senators’ investigation. the report said.

The FDA reviewed more than 1,000 comments submitted on the rule and made several changes in the final version released on Tuesday. These include reducing the maximum sound power of the device and modifying the insertion depth limit in the ear canal. The rule also requires hearing aids to have user-adjustable volume controls and simplified wording on product labels.

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