October 14, 2021

Warren, Grassley Call on FDA to Issue Over-the-Counter Hearing Aid Regulations

New Rules Would Implement Senators’ Legislation to Spur More Competition in the Hearing Aid Market, Expanding Access and Reducing Costs

Text of Letter (PDF)

Washington, D.C. - United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) urged the Food and Drug Administration (FDA) to issue new regulations for over-the-counter (OTC) hearing aids without delay, in accordance with President Biden’s Executive Order on Promoting Competition in the American Economy and their bill, the Over-the-Counter Hearing Aid Act, which was signed into law over four years ago.

“We appreciate the President’s commitment to promoting over-the-counter hearing aids for Americans with hearing loss...We urge your office to finalize the rule without delay,” the senators wrote.

More than 38 million Americans experience some degree of hearing loss. Older Americans are particularly affected, with nearly one in three people between the ages of 65 and 75, and around half of adults 75 or older reporting difficulty hearing. Yet, only 14% of people use hearing aids, primarily due to high costs. Hearing aids are not generally covered by health insurance or traditional Medicare and can cost thousands of dollars, making them prohibitively expensive for many Americans.

Senators Warren and Grassley’s Over-the-Counter Hearing Aid Act, which was signed into law over four years ago, removes outdated regulations blocking consumer access to affordable hearing aids and allows certain types of hearing aids to be made available over-the-counter to Americans with mild or moderate hearing loss. By introducing more competition into the hearing aid market, the law will provide consumers with more options at a price they can afford. The bill was passed into law in 2017 as a part of the FDA Reauthorization Act of 2017, but FDA has not yet issued final regulations implementing the law.

In July, President Biden issued an executive order directing HHS to “publish for notice and comment a proposed rule on over-the-counter hearing aids” within 120 days of the order, which falls on November 6, 2021. In their letter, Senators Warren and Grassley urge FDA to finalize the rule without delay and state their expectation that a final rule will promote competition, reflect the best interest of consumers and the public, and not contain any unnecessary restrictions to the devices or their utility.