Sen. Cramer, Colleagues Urge FDA to Finalize Rule on Over-The-Counter Hearing Aids

Source: United States Senator Kevin Cramer (R-ND)

WASHINGTON – U.S. Senator Kevin Cramer (R-ND) joined Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) on a letter to Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), expressing support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids.

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 letter urges 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 senators wrote.

Specifically, the senators 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.

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.

Senators Cramer, Warren, and Grassley are joined on the letter by Senators Patrick Leahy (D-VT), Marsha Blackburn (R-TN), Maggie Hassan (D-NH), Rick Scott (R-FL), Lindsey Graham (R-SC), Chris Van Hollen (D-MD), Bernie Sanders (I-VT), and Rand Paul (R-KY).