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, according to an announcement published on Grassley’s website. 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, according to the announcement. 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.

The FDA’s proposed rules for OTC hearing aids, a 114-page document that surprised many in its scope regarding rule changes for hearing aids in general, elicited over 1000 comments on the FDA website—comments to which the FDA is obligated to respond. The final rules are due to be published sometime around July. However, because of the number of comments and complexity of the issues, there has been speculation that the final rules may not be issued until around the end of the year or later.

Related Podcast: OTC Hearing Aids and How FDA Rules Might Change Hearing Care, with Dr Tom Powers

“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. 

“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. 

Related Article: FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

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

Additional original cosponsors of the legislation include Sens. Maggie Hassan (D-NH) and Marsha Blackburn (R-Tenn). 

Source: Sen. Chuck Grassley

Revised April 13, 2022