fda otc hearing aid rule

Grassley, Warren Introduce Bill to Increase Pressure on FDA to Issue Final OTC Hearing Aid Rule

WASHINGTON, D.C. — Today, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) introduced new legislation that would require the Food and Drug Administration (FDA) to issue a final rule regarding over-the-counter hearing aids.
Their bipartisan Delivering Over-the-Counter Hearing Aids Now Act follows the FDA’s proposed rule implementing over-the-counter hearing aids in October 2021, which was issued more than a year after the statutory deadline and over four years after the law’s passage. This bill would apply additional pressure on FDA to finalize the rule, requiring the agency to issue a final rule within 30 days following enactment. 
In July 2021, President Biden signaled his support for over-the-counter hearing aids in his Executive Order on Promoting Competition in the American Economy.
“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. 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”
–Senator Chuck Grassley (R-Iowa)
“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. This rule is long overdue, and the FDA needs to act with urgency – not buckle to the pressure of 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,” Warren said.
In 2017, Congress passed the FDA Reauthorization Act, which included Grassley’s and Warren’s Over-the-Counter Hearing Aid Act, requiring 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.
More than 38 million Americans experience some degree of hearing loss. Older Americans are particularly affected, with nearly half of adults 75 or older reporting difficulty hearing. Despite the prevalence of hearing loss, only one in five people who could benefit from a hearing aid use one, which many attribute to high costs.
Grassley’s and Warren’s Over-the-Counter Hearing Aid Act “removes outdated regulations that block consumer access to affordable hearing aids, and it allows certain types of hearing aids to be made available over-the-counter to Americans with mild or moderate hearing loss”. 
Additional original cosponsors of the legislation include Sens. Maggie Hassan (D-N.H.) and Marsha Blackburn (R-Tenn.).

Interested to learn more about what’s in the FDA’s proposed OTC hearing aid rule? Watch or listen to Dr. Tom Tedeschi provide a breakdown of the proposal at the 2021 Academy of Doctors of Audiology conference:


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