fda otc hearing aid rule

Senators Call on FDA to Issue Over-the-Counter Hearing Aid Regulations by November 6th

WASHINGTON D.C. – United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) urged the Food and Drug Administration (FDA) to issue new regulations for over-the-counter (OTC) hearing aids without delay, in accordance with President Biden’s Executive Order on Promoting Competition in the American Economy and their bill, the Over-the-Counter Hearing Aid Act, which was signed into law over four years ago.

“On July 9, 2021 President Biden directed the Department of Health and Human Services to “publish for notice and comment a proposed rule on over-the-counter hearing aids” within 120 days of the order.9 We appreciate the President’s commitment to promoting over-the-counter hearing aids for Americans with hearing loss and are encouraged that the Office of Information and Regulatory Affairs has completed its review of the proposed rule.10 We urge your office to finalize the rule without delay to, at a minimum, meet the deadline set forth in the President’s executive order.”

–Senators Grassley and Warren in letter to FDA

Elizabeth Warren (D-MA)

More than 38 million Americans experience some degree of hearing loss. Older Americans are particularly affected, with nearly one in three people between the ages of 65 and 75, and around half of adults 75 or older reporting difficulty hearing. Yet, only 14% of people use hearing aids, which has been attributed to high costs. Hearing aids are not generally covered by health insurance or traditional Medicare and can cost thousands of dollar.

Senators Warren and Grassley’s Over-the-Counter Hearing Aid Actwhich was signed into law over four years ago, “removes outdated regulations blocking consumer access to affordable hearing aids and allows certain types of hearing aids to be made available over-the-counter to Americans with mild or moderate hearing loss”.

grassley hearing aid bill
Chuck Grassley (R-IA)

According to the bill’s authors, introducing more competition into the hearing aid market the law will provide consumers with more options at a price they can afford. The bill was passed into law in 2017 as a part of the FDA Reauthorization Act of 2017, but FDA has not yet issued final regulations implementing the law.

In July, President Biden issued an executive order directing HHS to “publish for notice and comment a proposed rule on over-the-counter hearing aids” within 120 days of the order, which falls on November 6, 2021.

In their letter, Senators Warren and Grassley urge FDA to finalize the rule without delay and state their expectation that a final rule will promote competition, reflect the best interest of consumers and the public, and not contain any unnecessary restrictions to the devices or their utility.

Read the full text of the letter here


Source: Office of Senator Warren



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