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 Associated Press
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 devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. The FDA first proposed the rule last October. The new rule will take effect in mid-October.
Cost is a big obstacle now. Between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests. 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. The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face penalties, such as fines or product seizures.
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