Legal

Senators pressure FDA to lower cost of hearing aids

Only 1 in 5 Americans use hearing aids because of the prohibitive costs — an average of $2,500 — so two senators are telling the FDA to stop dragging their feet to issue new regulations allowing over-the-counter hearing aids.

Two senators introduced a bill Friday to speed up regulation that will allow consumers to buy over-the-counter hearing aids, after nearly a five-year delay. Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) introduced the bill that would give the Food and Drug Administration 30 days from when the bill is enacted to pass regulation allowing hearing aids to be bought off the shelf instead of with a prescription. 

“I hear from Iowans all the time about the high cost of hearing aids – sometimes as high as $10,000. These prices are often shocking for seniors on a fixed income,” Senator Grassley said in a news release. “Our bipartisan proposal will build on the important work we’ve already done to ensure that 38 million Americans who suffer from hearing loss have access to high-quality, affordable hearing aids,” Grassley said. 

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The proposed OTC regulations would allow adults with mild to moderate hearing loss to obtain hearing aids that are self-fit without a prescription. With hearing aids costing an average of $2,500, the FDA’s proposed rule in October was welcome news for the millions of people who experience hearing loss. But the agency has yet to follow up with specific guidelines so companies and consumers can begin to take advantage.

The idea of over-the-counter hearing aids has been in the works for years. Back in 2015, a report by the President’s Council of Advisors on Science and Technology recommended creating a class of over-the-counter hearing aids, noting that only a fraction of older adults with hearing loss use them. Two years later, Congress passed the Over-the-Counter Hearing Aid Act, creating this class of devices.

“Almost five years ago, Senator Chuck Grassley and I passed our bipartisan bill to allow hearing aids to be sold over-the-counter, but the FDA has yet to finalize the rule to implement it,” Senator Warren said in the release. “This rule is long overdue, and the FDA needs to act with urgency – not buckle to the pressure of entrenched corporate interests – to finalize a strong rule that will increase competition, lower costs for consumers, and ensure that people can finally buy hearing aids right off the shelf.” 

 According to the bill, only 1 in 5 Americans who could benefit from hearing aids use them because they can’t afford them. 

“The high cost of hearing aids, which are not generally covered by private health insurance plans or under traditional Medicare, makes them prohibitively expensive for many individuals in the United States and limits access,” the bill states. 

Additional reporting by Elise Reuter and Nancy M. Williams.

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