Cheaper Hearing Aids Coming Onto the Market

Getting a hearing aid should be less of a hassle — and eventually less expensive — under new rules introduced by the U.S. Food and Drug Administration.

The FDA said early in December it will no longer enforce a requirement that people aged 18 and older receive a medical evaluation or sign a waiver before buying most hearing aids.

The agency said it will also consider creating a category of over-the-counter hearing aids that could provide innovative and lower-cost devices to millions of Americans.

Currently, a pair of hearing aids typically costs $4,000 or more, putting them out of reach for the majority of older Americans who need them.

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” FDA Commissioner Robert Califf said in an agency news release.

Critics had argued that existing FDA rules were a potential barrier to people getting hearing aids, and provided little to no benefit to patients.

Changes to the FDA rules, which take effect immediately, could lead to technological breakthroughs that result in less-expensive hearing-aid options, according to the council.

Although some 30 million people in the United States suffer from hearing loss, only about one-fifth who could benefit from a hearing aid seek help.

The FDA said it will continue to enforce the medical evaluation requirement for prospective hearing aid users younger than 18.
The agency will also continue to require that hearing aid labels include information about medical conditions that should be evaluated by a doctor. Also, licensed hearing aid dispensers must still give consumers information and instructions about hearing aids before purchase.