Over-the-counter hearing aids are expected in the US this fall

WASHINGTON (AP) — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule that was finalized Tuesday.

The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a physical exam, prescription, and other professional evaluations. The devices are sold online or over the counter in pharmacies and other retail outlets.

The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aids, but only about a fifth of people with hearing problems currently use the devices.

“Today’s action by the FDA marks a significant milestone in making hearing aids more affordable and accessible,” Xavier Becerra, Secretary of Health and Human Services, told reporters on Tuesday.

The FDA first proposed the rule last year, and it will go into effect in mid-October. The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and more readily available.

Cost is now a major obstacle. Americans can pay upwards of $5,000 for a hearing aid, along with the device itself and fitting services. Insurance coverage is limited and Medicare does not pay for hearing aids, only diagnostic tests.

“The requirement to see a specialist has not only been a burden and annoyance for many consumers, but it has actually created a competitive barrier to entry,” said Brian Deese, a White House economic adviser.

Deese cited government estimates that Americans could ultimately save as much as $2,800 per pair. But FDA officials warned against predicting the amount of savings or how quickly they might arrive, since much will depend on when manufacturers launch products and how they price them.

“It’s very difficult to predict exactly what we’re going to see and when,” said Dr. Jeffrey Shuren, head of the FDA’s Medical Devices Agency.

According to Shuren, officials expect increased competition from new manufacturers as well as new products from existing hearing aid manufacturers.

The new over-the-counter status does not apply to devices for more severe hearing loss, which remain prescription-only.

Consumer electronics companies have been making lower-cost personal sound amplification devices for years, but they don’t undergo FDA review, and US regulations prohibit them from being marketed as hearing aids. The new rule makes it clear that these devices are not alternatives to FDA-approved hearing aids.

The FDA said it changed several parts of its original proposal in response to public comments, including clarifying how the rule will affect state regulations.

Tuesday’s announcement follows urging from medical committees and Congress, which directed the agency in 2017 to develop an over-the-counter hearing aid plan.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

https://www.wane.com/top-stories/over-the-counter-hearing-aids-expected-this-fall-in-us/ Over-the-counter hearing aids are expected in the US this fall

Tom Vazquez

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