WASHINGTON –
Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule that was finalized on Tuesday.
The regulation creates a new class of hearing aids that do not require a physical exam, prescription and other specialist evaluations, the Food and Drug Administration said. That is expected to increase competition and ultimately reduce costs. The devices will be sold online or over-the-counter at pharmacies and other retail stores.
This device is intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could benefit from hearing aids, although only about one-fifth of people with hearing problems currently use hearing aids.
“Today’s action by the FDA represents an important milestone in making hearing aids more affordable and accessible,” Secretary of Health and Human Services Xavier Becerra told reporters. reporters on Tuesday.
The FDA first proposed the rule last year, and it will go into effect in mid-October. The move comes after years of pressure from health experts and consumer advocates to make it clear. for devices that are cheaper and easier to buy.
Cost is a major obstacle these days. Americans can pay more than $5,000 for a hearing aid, between the device and the fitting service. Coverage is limited and Medicare does not pay for hearing aids but only for diagnostic tests.
“The requirement to see an expert is not only burdensome and uncomfortable for many consumers, but it actually creates a competitive barrier to entry,” said Brian Deese, economic adviser to the White House.
Deese cites government estimates that Americans could end up saving up to $2,800 per pair. But FDA officials cautioned against predicting the size of the savings or how quickly they might arrive, noting much will depend on when manufacturers release products and how they price them. .
FDA officials said they expect increased competition from new manufacturers as well as new products from existing hearing aid makers.
According to Kate Carr, president of the Hearing Industry Association, which represents manufacturers, medical tests and accessories currently account for about two-thirds of the cost of hearing aids. Five companies, she noted, make most of the devices sold in the US, though about 80 have registered with the FDA to market the products.
“Given that this has been discussed for five years now, I doubt businesses have had a chance to think about their plans and prepare for this,” Carr said.
The new over-the-counter status will not apply to more severe hearing loss devices, but will only apply to prescriptions.
Glenda Greer, of Loudon, Tennessee, said she struggled to hear conversations at work and in crowded restaurants for seven years before recently being fitted with her first hearing aid. .
“It just makes things a lot easier because I don’t have to focus on people’s faces and try to read lips,” said Greer, a recently retired nurse. said.
Consumer electronics companies have for years produced lower-cost “personal audio amplifiers” devices, but they haven’t undergone FDA review and US regulations forbid them from being sold. marketed as hearing aids.
The FDA said it changed several parts of the original proposal in response to public comments, including clarifying how the rule would impact state regulations.
Tuesday’s announcement comes at the urging of health committees and Congress, which in 2017 directed the agency to plan for over-the-counter hearing aids.
The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute’s Science Education Department. AP is solely responsible for all content.
