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In a letter to U.S. Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) expressed their 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 in 2017.

“We write to urge the FDA to finalize the rule without delay,” the senators said. “To ensure the final regulation is consistent with congressional intent, it must not contain any unnecessary restrictions that hinder access to over-the-counter (OTC) devices or their utility for Americans with mild or moderate hearing loss. For these reasons, we strongly support maintaining the maximum sound pressure level identified in the proposed rule and oppose the introduction of any limits on gain. In addition, we believe that federal preemption of state laws governing the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC products is necessary to ensure consumers can access these devices without interference, as the Over-the-Counter Hearing Aid Actestablished.

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“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 continued.

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.

“As we have written FDA leadership before, we hope to see a final rule that promotes competition and reflects the best interests of consumers and the public. We ask you to finalize this rule without delay and in a manner that is consistent with congressional intent,” the senators concluded.

Grassley and Warren’s Over-the-Counter Hearing Aid Act removes outdated regulations that block consumer access to affordable hearing aids, and it allows certain types of hearing aids to be made available over-the-counter to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 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 June, Grassley pressed HHS Secretary Xavier Becerra on the FDA issuing OTC hearing aid regulations at a Senate Finance Committee hearing; and last October, the FDA issued a proposal for OTC hearing aid regulations after Sens. Grassley and Warren pressed the agency to issue the regulations without delay.

FDA’s proposed regulation was posted on the Federal Register here on October 20, 2021, for a 90 day comment period. The FDA will now review public comments and issue a final regulation. Once issued, the final regulation will take effect after 60 days.

Read the letter by clicking HERE.

Author: Press Release

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