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.
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. "It’s very hard to predict exactly what we’ll see and when," said Dr. Jeffrey Shuren, the FDA's medical device chief.
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