Blackburn, Colleagues Increase Pressure on FDA to Issue Final Rule on Over-the-Counter Hearing Aids

April 25, 2022

WASHINGTON, D.C. – U.S. Senator Marsha Blackburn (R-Tenn.) along with Senators Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), and Maggie Hassan (D-N.H.) introduced new legislation that would require the Food and Drug Administration (FDA) to issue a final rule regarding access to over-the-counter hearing aids. This legislation follows up on a proposed rule the FDA issued in October 2021, more than a year after the statutory deadline set in 2017 by the Over-the-Counter Hearing Aid Act. This bill would require the agency to issue a final rule within 30 days following enactment of the bill.


“Since President Trump signed the Over-the-Counter Hearing Aid Act in 2017, the FDA has done little to expand hearing aid access for the more than 38 million Americans struggling with hearing loss,” said Senator Blackburn. “I’ve been fighting to make affordable, accessible over-the-counter hearing aids a reality since I served in the U.S. House of Representatives. This legislation will pressure the FDA to finish the work we started almost five years ago and ensure that regulatory red tape doesn’t stop Tennesseans from getting access to the treatment they deserve.”


“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 entrenched 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," said Senator Warren.


“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,” Grassley said.




  • In 2017, Congress passed the FDA Reauthorization Act, which included the Over-the-Counter Hearing Aid Act then Representative Blackburn supportedwhich would require the FDA to issue implementing regulations to establish 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, mainly due to high costs. Hearing aids are not generally covered by private health insurance plans or traditional Medicare and can cost thousands of dollars – making them prohibitively expensive for many Americans.


  • The 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. By introducing more competition into the hearing aid market, the law will provide consumers with more options at a price they can afford.