The FDA’s proposal for over-the-counter hearing aids has met with mixed responses from manufacturers


MedCity News

Soon people will be able to buy hearing aids without having to undergo a hearing exam or fitting. The Food and Drug Administration on Tuesday issued a proposed rule that would allow adults to purchase the devices over the counter with the aim of making them more affordable and accessible.

With hearing aids averaging $ 2,500 apiece, the FDA announcement was welcome news for the millions of people who suffer from hearing loss. However, it met with mixed feedback from manufacturers.

Six companies currently manufacture most of the hearing aids. One of the largest Sonova, based in Switzerland, did not comment directly on the FDA regulations, but bought the consumer division of the headphone manufacturer Sennheiser in May. Another consumer electronics company, Bose, launched an FDA-cleared, self-fitting hearing aid earlier this year.

Starkey Hearing Technologies, a large US manufacturer, has raised its concerns about the proposed changes.

“We support efforts to improve the accessibility and affordability of hearing aids, but we believe that better hearing is best achieved through the hearing care professional,” wrote CEO Brandon Sawalich in an emailed statement.

He also shared some specific concerns with the proposed rule, saying that the recommended output limits should be reduced to 110 decibels and that there should be a limit to the maximum gain, or gain, of a hearing aid.

“We’re still analyzing the entirety of the FDA’s proposed regulations for OTC hearing aids, but aside from not including the hearing care professional, there are some initial concerns about patient safety and satisfaction,” he wrote.

On the other hand, Audicus, a new participant using a free online hearing test, was more supportive of the proposed rule. It doesn’t make its own hearing aids, instead it buys them from manufacturers and sells them at a cheaper price than most hearing clinics.

“We welcome the regulation proposed by the FDA to create a class of OTC hearing aids and see it as a milestone for better access,” wrote CEO Patrick Freuler in an email. “It will only allow us to continue reaching those in need of hearing solutions and provide them with life-changing devices at a fraction of the cost of traditional channels.”

The particularities
The rule proposed by the FDA would only apply to hearing aids for adults with mild to moderate hearing loss. Children would need a medical exam before using a hearing aid.

Devices would be limited to a maximum output of 115 decibels or 120 dB if the device has an adjustable volume. The FDA does not plan to limit the maximum gain as it would “inappropriately restrict” the design of devices and that the maximum output levels should be sufficient for user safety.

The agency also reviews other performance requirements such as distortion, noise, and latency limits.

The idea of ​​over-the-counter hearing aids has been in the works for years. Back in 2015, a report from the President’s Advisory Council on Science and Technology recommended the creation of a class of over-the-counter hearing aids and found that only a fraction of older adults with hearing loss use them. Two years later, Congress passed the Over-the-Counter Hearing Aid Act, which created this class of equipment.

The FDA is expected to finalize the prescription next year. The Hearing Loss Association of America (HLAA), a consumer protection group that backed the legislation, said it expected it would be a year or more before over-the-counter hearing aids hit the market.

“We hope that many adults who qualify for these devices will be encouraged to take this important step towards good hearing health,” wrote Barbara Kelley, Executive Director of the HLAA, in a press release.

The rule change would effectively remove the requirement that people need a medical exam to buy a hearing aid and regulate hearing aids for severe hearing loss or for children as prescription devices.

Photo credit: PIKSEL, Getty Images

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