US regulators lay out plan for over-the-counter hearing aids
WASHINGTON (AP) – U.S. health officials are laying out plans to let most Americans buy hearing aids without a prescription. Tuesday’s announcement is a long-awaited move intended to make the devices more accessible to millions of Americans with hearing problems.
The Food and Drug Administration said the proposal would let people with mild-to-moderate hearing loss buy hearing aids at pharmacies and other stores.
More than 15% of U.S. adults have trouble hearing. But only about one-fifth of people who can benefit from hearing aids use one.
According to the FDA website, there are no products that can be legally marketed as over-the-counter (OTC) hearing aids. The FDA Reauthorization Act of 2017 (FDARA) details certain requirements to establish a category of over-the-counter (OTC) hearing aids and the kinds of regulatory requirements that will apply to them. To establish the OTC category and realign other regulations for hearing aids, the FDA published proposed regulations for public comment and will eventually publish final regulations, taking public comments into account.
Getting a hearing aid and having it fitted can cost $5,000. Insurance coverage is limited, and Medicare doesn’t pay for hearing aids.