FDA moves to allow many Americans to buy hearing aids without a prescription
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 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.
The new over-the-counter status won't apply to devices for more severe hearing loss, which will remain prescription only.The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids.
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.