Over-the-counter hearing aids are expected this fall in the US after the FDA finalizes a long-awaited rule to cut red tape
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 Food and Drug Administration said the new regulations cut red tape by creating a new class of hearing aids that don’t require medical exams, prescriptions and other specialist evaluations. 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 hearing aids, but only about one-fifth of people with hearing problems currently use them.
“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.
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 easier to obtain.
Cost is a big hurdle now. Americans can pay upwards of $5,000 for a hearing aid, between the device itself 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.
“It’s very difficult to predict exactly what we’ll see and when,” said Dr. Jeffrey Shuren, chief medical device officer for the FDA.
Shuren said officials expect to see increased competition from new manufacturers as well as new products from existing hearing aid manufacturers.
The new over-the-counter status will not apply to devices for more severe hearing loss, which will remain prescription-only.
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 new rule clarifies 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 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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