WASHINGTON — 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. These devices will instead be available online and at other retailers, as well as over-the counter in pharmacies.
They are designed for people with moderate to severe hearing impairments. According to the FDA, nearly 30 million people could benefit from hearing aids. However, only one-fifth (or less) of those with hearing impairments currently use hearing aids. In October last year, the FDA proposed this rule. In mid-October, the new rule will go into effect.
Officials from the Biden Administration highlighted potential savings.
“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, said in a statement.
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This move comes after years of consumer advocacy and medical professionals pushing for the device to be cheaper and more accessible.
Now, cost is an issue. Americans will need to pay over $5,000 for a hearing aid, including the cost of fitting it and additional costs. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests.
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 U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. These devices cannot be used as alternatives to FDA-approved hearing aids. They could be subject to fines and product seizes if they are marketed in an inappropriate manner.
After receiving public feedback, the FDA changed parts of their initial proposal. It also clarified how the federal rule would affect state regulations regarding hearing aids.
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Traditional manufacturers will likely start selling direct to consumers models at a lower price once the federal rule goes into effect. Advocates predict that the market for hearing aids will eventually mirror eye care where customers can select between prescription bifocals or drugstore reading glasses.
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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