February 09, 2022

Warren, Grassley Lead Bipartisan Call On FDA to Finalize Rule on OTC Hearing Aids Without Delay

Lawmakers Express Support for Maintaining The Rule’s Maximum Output Limit and Preemption of State Laws That Block Consumer Access

Text of Letter (PDF)

Washington, D.C. — United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) led their colleagues in a letter to Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration, expressing support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids. The FDA’s proposed rule is a direct result of the Over-the-Counter Hearing Aid Act, which Grassley and Warren ushered through Congress with broad bipartisan support in 2017. 

The comment period on FDA’s proposed regulation ended on January 18, 2022. With the public comment period now closed, the senators are calling on the FDA to finalize the rule without delay and in a manner that is consistent with congressional intent. Once issued, the final regulation will take effect after 60 days. 

The senators are urging the FDA to exclude any unnecessary restrictions that hinder access to OTC devices or limit their effectiveness for Americans with mild or moderate hearing loss. 

“Maintaining these provisions will ensure that the final regulation successfully increases competition, spurs innovation, and brings down prices for consumers, while meeting the high standards of safety, manufacturing protections, and consumer labeling required of all medical devices,” the lawmakers wrote.

Specifically, Warren and Grassley are pushing to:

  • Maintain the maximum sound pressure level identified in the proposed rule and prevent the introduction of any limits on gain. These standards will ensure the maximum effectiveness and innovation of OTC devices without compromising consumer safety.
  • Maintain the federal preemption of state laws governing the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC products, which are necessary to ensure consumers can access these devices without interference. Without federal preemption, a wide array of state laws would prevent consumers from easily and directly accessing OTC hearing aids, limiting the number of consumers who would otherwise be helped by this law. 

The letter is also signed by Senators Patrick Leahy (D-Vt.), Marsha Blackburn (R-Tenn.), Maggie Hassan (D-N.H.), Rick Scott (R-Fla.), Lindsey Graham (R-S.C.), Chris Van Hollen (D-Md.), Bernie Sanders (I-Vt.), Kevin Cramer (R-N.D.), Rand Paul (Ky.).

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.

Warren and Grassley’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 provide consumers with more options at a price they can afford.

The senators have repeatedly called on the FDA and the Department of Health and Human Services (HHS) to take action over the last four years. Last October, the FDA issued a proposal for OTC hearing aid regulations after Senators Warren and Grassley pressed the agency to issue the regulations without delay.