The regulation creates a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations, the Food and Drug Administration said. That’s expected to increase competition and eventually lower costs.
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, though only about one-fifth of people with hearing problems currently use one.
Cost is a big obstacle now. Americans can pay more than $5,000 for a hearing aid, between the device and fitting services. Insurance coverage is limited and Medicare doesn’t pay for hearing aids, only diagnostic tests. FDA officials said they expect to see increased competition from new manufacturers as well as new products from existing hearing aid makers.
The new over-the-counter status won’t apply to devices for more severe hearing loss, which will remain prescription only.
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