Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule 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 medical exam, a prescription and other specialty 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 use the devices currently.
"Today's action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible," Health and Human Services Secretary Xavier Becerra told reporters Tuesday.
Steep costs and no Medicare coverage
The FDA firstand it will take effect in mid-October. The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.
Cost is a big obstacle now. Americans can pay more than $5,000 for a hearing aid, between the device itself and fitting services. Insurance coverage is limited and Medicare doesn't pay for hearing aids, only diagnostic tests. Most forms of Medicaid, geared to low-income people, also doesn't cover the cost.
"The requirement to see 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, a White House economics adviser.
Deese cited government estimates that Americans could eventually save as much as $2,800 per pair. But FDA officials cautioned against predicting the size of savings or how quickly they might arrive, noting much will depend on when manufacturers launch products and how they price them.
"It's very hard to predict exactly what we'll see and when," said Dr. Jeffrey Shuren, the FDA's medical device chief.
But Shuren said officials expect to see increased competition from new manufacturers as well as new products from existing hearing aid makers.
Bring on the iAid?
Companies like Bose, Samsung and perhaps even Apple could introduce over-the-counter hearing aids, Dr. Justin Golub, an ear specialist at Columbia University Medical Center in New York,. Eventually, the entry of major tech players in the market for the devices is likely to drive costs down, he added.
Bose has an $850 self-fitting hearing aid cleared by the FDA for direct-to-consumer sales and available for purchase online. Apple in 2013 began including Bluetooth software for its iPhone that is compatible with hearing aids and offers other hearing-oriented device features, including dampeners and amplification. Costco, through its Kirkland brand, sells hearing aids for about $1,400.
The new over-the-counter status won't apply to devices for more severe hearing loss, which will remain prescription only.
Consumer electronic companies for years have produced lower-cost "personal sound amplification" devices, but they do not undergo FDA review and U.S. regulations bar them from being marketed as hearing aids. The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids.
The FDA said it changed several parts of its initial proposal in response to public comments, including clarifying how the rule will impact state regulations.
Tuesday's announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices.
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