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Grassley, Warren Applaud FDA Clearance of Major Regulatory Hurdle for OTC Hearing Aids

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) today praised the Food and Drug Administration’s (FDA) announcement of the newly proposed over-the-counter (OTC) hearing aids regulations which implements the Grassley-Warren 2017 law. This comes after the senators pressed the FDA Commissioner last week to issue the regulations without delay.

“We’ve just cleared a major regulatory hurdle for over-the-counter hearing aids,” the senators said. “Soon, millions of people with mild to moderate hearing loss will finally have lower cost hearing aid options – and more options mean more competition in the market, further driving down the cost for consumers. This is terrific news.”

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, primarily due to high costs. Hearing aids are not generally covered by health insurance or traditional Medicare and can cost thousands of dollars, making them prohibitively expensive for many Americans.

Grassley and Warren’s Over-the-Counter Hearing Aid Act removes outdated regulations blocking consumer access to affordable hearing aids and allows certain types of hearing aids to be made available over-the-counter to Americans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. By 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 but FDA has not yet issued final regulations implementing the law.

The senators have called on the FDA and the Department of Health and Human Services (HHS) to take action over the last four years. Most recently, Grassley pressed HHS Secretary Xavier Becerra on the FDA issuing OTC hearing aid regulations at a Senate Finance Committee hearing on the HHS FY 2022 Budget.

FDA’s proposed regulation is posted on the Federal Register here. There is a 90 day comment period. Following the comment period, FDA will issue a final regulation effective 60 days following that notice.

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