New law permits OTC hearing aid sales, lower consumer costs projected

The Over-the-Counter Hearing Aid Act of 2017, included in a larger bill reauthorizing the U.S. Food and Drug Administration (FDA), became law Aug. 18 when President Donald Trump officially signed it.

U.S. Rep. Vern Buchanan (R-FL), a bill co-sponsor, said specific hearing aids now will be more affordable for millions of Americans.

“This bill could help improve the quality of life for nearly 50 million Americans who struggle to hear everyday conversations,” Buchanan said Monday. “Many people who need hearing aids cannot afford the high price tag of $4,000 or more.”

Approximately 48 million Americans experience age-related hearing loss yet roughly 14 percent of them use hearing aids because they’re not covered by Medicare and out-of-pocket costs average $2,400 on private insurance plans.

Buchanan said the new law is projected to help bring down the cost of hearing aids from several thousand dollars to a few hundred dollars.

Specifically, the bipartisan legislation is targeted to adults with moderate hearing loss, who now can purchase over-the-counter (OTC) hearing aids through an easier, more cost-effective process, he said.

Currently, a formal medical evaluation is required before consumers can purchase hearing aids, which are most often bought from audiologists or licensed hearing aid sellers after an evaluation. The  Over-the-Counter Hearing Aid Act of 2017 removes these requirements, said Buchanan.

U.S. Sen. Chuck Grassley (R-IA), a lead co-sponsor of the original bill, said hearing aids are mostly sold with “bundled” fees for evaluations, follow-up appointments and adjustments that drive up costs and limit consumer access.  

“Consumers are interested in new hearing aid products to improve their quality of life at an affordable price. The more products available, the more consumers will be able to find something they can afford that works for them,” Grassley said earlier this week.

Grassley also pointed out that the bicameral measure requires the FDA to issue regulations for the new category of OTC hearing aids to ensure they meet safety standards and the same consumer labeling and manufacturing protections as all medical devices.