WASHINGTON (AP) — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized on Tuesday.
The regulations create a new class of hearing aids that don’t require medical exams, prescriptions and other specialized evaluations, the Food and Drug Administration said. This should increase competition and possibly reduce costs. The devices will be sold online or over the counter at pharmacies and other retail stores.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from a hearing aid, although only about a fifth of people with hearing problems currently use one.
“Today’s action by the FDA represents an important step in making hearing aids more cost-effective and more accessible,” Health and Human Services Secretary Xavier Becerra told reporters on Tuesday.
FDA first proposed rule last year and will come into force in mid-October. The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to obtain.
Cost is a big hurdle now. Americans can pay upwards of $5,000 for a hearing aid, between device and fitting services. Insurance coverage is limited and Medicare does not pay for hearing aids, only diagnostic tests.
“The requirement to consult a specialist was not only a burden and an annoyance for many consumers, but it actually created a competitive barrier to entry,” said Brian Deese, White House economic adviser.
Deese cited government estimates that Americans could potentially save up to $2,800 per pair. But FDA officials cautioned against predicting how big or how quickly the savings could come, noting that it will all depend on when manufacturers launch the products and how they price them.
FDA officials said they expect to see increased competition from new manufacturers as well as new products from existing hearing aid manufacturers.
Medical exams and fittings now account for about two-thirds of the cost of hearing aids, according to Kate Carr, president of the Hearing Industries Association, which represents manufacturers. Five companies make most of the devices sold in the United States, she noted, although about 80 companies are registered with the FDA to market the products.
“Given that it’s been talked about for five years now, I suspect companies have had a chance to think through their plans and prepare for it,” Carr said.
The new over-the-counter status will not apply to devices for more severe hearing loss, which will remain prescription-only.
Glenda Greer, from Loudon, Tennessee, said she struggled to hear conversations at work and in crowded restaurants for seven years before she was recently fitted for her first hearing aid.
“It made it so much easier because I didn’t have to focus on people’s faces and try to read lips,” said Greer, a recently retired nurse.
For years, consumer electronics companies have been producing cheap “personal sound amplification” devices, but they are not subject to FDA review and US regulations prevent them from being marketed. as hearing aids.
The FDA said it changed several parts of its original proposal in response to public comments, including clarifying the rule’s impact on state regulations.
Tuesday’s announcement follows prompting from medical committees and Congress, which in 2017 asked the agency to introduce a plan for over-the-counter hearing aids.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.