FDA Moves to Expand Access to Hearing Aids
By Jonathan Springston, Assistant Editor, AHC Media
The FDA announced this week steps it is taking to expand consumer access to hearing aids, building on earlier presidential and congressional recommendations.
First, the agency says it no longer will enforce the rule requiring Americans 18 years of age or older to undergo a test before purchasing hearing aids (although those under 18 still must undergo such a test). Second, regulators will examine making hearing aids available for purchase over the counter (OTC). The agency says its making these moves to help the 30 million Americans affecting by hearing impairment, noting that only one-fifth of those who need treatment currently seek it.
“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, MD. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”
Last year, the President’s Council of Advisors on Science and Technology issued recommendations for expanding consumer access to hearing aid access. Additionally, Sens. Chuck Grassley, R-IA, and Elizabeth Warren, D-MA, co-sponsored the Over-the-Counter Hearing Aid Act of 2016, part of which calls for making hearing aids available OTC.
“I'm very glad to see the FDA recognize that over-the-counter hearing aids can improve access to millions of Americans with untreated hearing loss,” Warren wrote in a Facebook post on Friday. “Our bill will make additional simple changes to help adults with hearing loss get access to hearing aids and make it easier for consumers to shop for the best value.”
One news outlet noted that OTC hearing aids could encourage more manufacturers into the market, thereby lowering costs. Today, hearing aids can cost more than $4,000, and because Medicare often doesn’t cover the expense, many consumers pay out of pocket.