Warren, Grassley Call on FDA to Issue Over-the-Counter Hearing Aid Regulations
New Rules Would Implement
Senators’ Legislation to Spur More Competition in the Hearing Aid Market,
Expanding Access and Reducing Costs
Text
of Letter (PDF)
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.
“We appreciate the President’s commitment to promoting over-the-counter hearing
aids for Americans with hearing loss...We urge your office to finalize the rule
without delay,” the senators wrote.
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.
Senators Warren and Grassley’s Over-the-Counter
Hearing Aid Act, which 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ago, removes outdated regulations blocking consumer access to affordable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. 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 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.
###
Next Article Previous Article
