October 19, 2021

Warren & Grassley: FDA Just Cleared Major Regulatory Hurdle for OTC Hearing Aids

Washington, DC -- United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) released the following statement on the Food and Drug Administration’s (FDA) issuing of its proposed over-the-counter (OTC) hearing aids regulations to effectively implement the Senators’ 2017 law.

“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” said the Senators in a joint statement. “Soon, millions of people with mild to moderate hearing loss will finally have lower cost hearing aid options -- and more options mean more competition in the market, further driving down the cost for consumers. This is terrific news.”

Senators Warren and Grassley’s Over-the-Counter Hearing Aid Act was signed into law over four years ago to remove outdated regulations blocking consumer access to affordable hearing aids and allow certain types of hearing aids to be made available over-the-counter to Americans with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.

In a letter sent last week, Senators Warren and Grassley urged the FDA to finalize the OTC hearing aids rule without further delay -- and in line with President Biden’s executive order. The senators stated 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. 

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.