FDA Eases Up on Hearing Aid Rules

Devices should be easier to obtain, less expensive under new guidelines

By Robert Preidt

Wednesday, December 7, 2016

WEDNESDAY, Dec. 7, 2016 (HealthDay News) -- 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 on Wednesday 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, according to the President's Council of Advisors on Science and Technology.

"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 Dr. Robert Califf said in an agency news release.

The President's advisory council and other critics had argued that existing FDA rules were a potential barrier to people getting hearing aids, and provided little to no benefit to patients.

"Untreated hearing loss, especially in older Americans, is a substantial national problem," the council said in a recent report. Hard-of-hearing seniors face significantly impaired communication, social participation and overall health and quality of life, the report noted.

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.

SOURCE: U.S. Food and Drug Administration, news release, Dec. 7, 2016

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