Letter to Janet Woodcock, Acting Commissioner, Food and Drug Administration - Grassley, Warren Call On FDA To Issue Long Overdue Over-The-Counter Hearing Aid Regulations

Letter

Dear Acting Commissioner Woodcock:
We write to urge the U.S. Food and Drug Administration (FDA) to issue the proposed rule
regarding over-the-counter hearing aids without delay and no later than November 6, 2021, in
accordance with President Biden's Executive Order on Promoting Competition in the American
Economy.1 We are pleased to see that the Office of Information and Regulatory Affairs has
recently completed its review of the proposed rule, more than four years since our Over-theCounter Hearing Aid Act was signed into law. As such, we request that you release the rule as
soon as possible.
More than 38 million Americans experience some degree of hearing loss.2 Older Americans are
particularly affected, with nearly one in three people between the ages of 65 and 753
and around
half of adults 75 or older reporting difficulty hearing.4 Americans with hearing loss are also more
likely to experience feelings of loneliness and isolation, which the COVID-19 pandemic has only
exacerbated.
5 Despite the prevalence of hearing loss, only 14% of people use hearing aids. One
of the primary reasons for this is cost. 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.6
President Trump signed the Over-the-Counter Hearing Aid Act into law in 2017. This law, based
on our bill with Senators Hassan and Isakson, removes outdated regulations blocking consumer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 to moderate hearing loss.7 By introducing more
competition into the hearing aid market, the law will provide consumers with more options at a
price they can afford. Yet, it has been four years since the Over-the-Counter Hearing Aid Act
was passed into law and we are still awaiting the proposed rule.8
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.
In doing so, it is our expectation that FDA will issue hearing aid regulations that are consistent
with the law and reflect the intent of the Over-the-Counter Hearing Aid Act to expand consumer
access to affordable hearing aids. Specifically, we hope that the rule does not contain any
unnecessary restrictions that hinder access to these devices or their utility. The regulations must
succeed in increasing competition, spurring innovation, and bringing down prices for consumers,
while meeting the high standards of safety, manufacturing protections, and consumer labeling
required of all medical devices. We hope to see a final promulgated rule that promotes
competition and reflects the best interests of consumers and the public.
We thank you for your time and consideration and look forward to the upcoming release of a
proposed rule.
Sincerely,

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