August 16, 2022

Warren, Grassley Praise FDA’s Finalized Over-the-Counter Hearing Aid Rule

Washington, D.C. – United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) issued the following joint statement after the Food and Drug Administration (FDA) finalized a key rule allowing hearing aids to be sold over-the-counter, an effort they have worked on since 2017:

"Five years after our bipartisan Over-the-Counter Hearing Aid Act became law, consumers with mild to moderate hearing loss will finally have access to affordable over-the-counter hearing aids,” said Warren and Grassley. “We’ve pressed the FDA to take action every step of the way – holding both Republican and Democratic administrations accountable – and fought back against entrenched special interests. We are thrilled that the FDA has finalized these guidelines and that safe, effective, accessible and affordable hearing aids will now be available over-the-counter for millions of Americans.”

In 2017, Congress passed the FDA Reauthorization Act, which included Warren and Grassley’s Over-the-Counter Hearing Aid Act. Their bill requires the FDA to issue regulations establishing over-the-counter hearing aids no later than three years from the date of enactment. The FDA finally did so last fall, more than four years after the Over-the-Counter Hearing Aid Act was signed into law. The public comment period closed on January 18, 2022.

At the end of June, Warren and Grassley released a comprehensive report showing how dominant hearing aid manufacturers were attempting to diminish the effectiveness of over-the-counter hearing aids. They also called on the FDA commissioner to adopt a final rule that promotes competition, reduces prices and meets high standards of safety and effectiveness.

The new guidelines officially go into effect 60 days following the FDA’s official notice today.