Grassley, Warren praise FDA’s finalized over-the-counter hearing aid rule

U.S. Sen. Chuck Grassley (R-Iowa)
Senator Warren (D-Mass)

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) 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 Grassley and Warren. “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.”

“Allowing Iowans, and all Americans, with mild to moderate hearing loss the option to shop for over-the-counter hear aids is a pocketbook issue, and a health and connection issue. Thank you to Senators Grassley and Warren for leading on the passage of the bipartisan law and their subsequent multi-year push to get the rule finalized,” said AARP Iowa State Director Brad Anderson.

“Implementation of the Over-the-Counter Hearing Aid Act will improve access and lower costs for many consumers. It will also demonstrate the essential role that audiologists play in the diagnosis and treatment of hearing loss and compliments Senator Warren’s and Senator Grassley’s commitment to modernize Medicare so that beneficiaries have better access to the audiology services that they need,” said Dr. Jason Aird, president and CEO of Iowa Audiology.

“I’ve been looking into buying hearing aids for a while now but I’ve held off because they are so expensive. Hearing aids are a necessity for those of us who struggle with hearing and want to stay sharp and prevent cognitive decline. I also want to clearly hear my grandkids tell me all about baseball and school, which means I know I’m going to need to invest in hearing aids soon. I’m grateful Sen. Grassley has been working to finally bring over-the-counter hearing aids to the market to give us some more high-quality, affordable options,” said Des Moines resident Jean Helm.

In 2017, Congress passed the FDA Reauthorization Act, which included Grassley’s and Warren’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, Grassley and Warren 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 on August 16.