WASHINGTON – Sens. Chuck Grassley
(R-Iowa) and Elizabeth Warren (D-Mass.) issued the following joint statement
after the Food and Drug Administration (FDA) finalized a key rule allowing
hearing aids to be sold over-the-counter, an effort they have worked on since 2017:
"Five years after our bipartisan Over-the-Counter Hearing Aid Act became
law, consumers with mild to moderate hearing loss will finally have access to
affordable over-the-counter hearing aids,” said
Grassley and Warren. “We’ve pressed the FDA to take action every step of
the way – holding both Republican and Democratic administrations accountable –
and fought back against entrenched special interests. We are thrilled that the
FDA has finalized these guidelines and that safe, effective, accessible and
affordable hearing aids will now be available over-the-counter for millions of
Americans.”
“Allowing Iowans, and all Americans, with
mild to moderate hearing loss the option to shop for over-the-counter hear aids
is a pocketbook issue, and a health and connection issue. Thank you to Senators
Grassley and Warren for leading on the passage of the bipartisan law and their
subsequent multi-year push to get the rule finalized,” said AARP Iowa State Director Brad Anderson.
“Implementation of the Over-the-Counter Hearing Aid Act will
improve access and lower costs for many consumers. It will also demonstrate the
essential role that audiologists play in the diagnosis and treatment of hearing
loss and compliments Senator Warren’s and Senator Grassley’s commitment to
modernize Medicare so that beneficiaries have better access to the audiology
services that they need,” said Dr. Jason
Aird, president and CEO of Iowa Audiology.
“I’ve been looking into buying hearing
aids for a while now but I’ve held off because they are so expensive. Hearing aids are a necessity for those of us
who struggle with hearing and want to stay sharp and prevent cognitive decline.
I also want to clearly hear my grandkids tell me all about baseball and school,
which means I know I’m going to need to invest in hearing aids soon. I’m grateful Sen. Grassley has been working
to finally bring over-the-counter hearing aids to the market to give us some
more high-quality, affordable options,” said
Des Moines resident Jean Helm.
In 2017, Congress passed the
FDA Reauthorization Act, which included
Grassley’s and Warren’s
Over-the-Counter
Hearing Aid Act. Their bill
requires the FDA to issue regulations establishing over-the-counter hearing
aids no later than three years from the date of enactment. The FDA finally did
so last fall, more than four years after the
Over-the-Counter Hearing Aid Act was signed into law. The public
comment period closed on January 18, 2022.
At the end of June, Grassley and Warren
released a comprehensive
report
showing how dominant hearing aid manufacturers were attempting to diminish the
effectiveness of over-the-counter hearing aids. They also called on the FDA
commissioner to adopt a final rule that promotes competition, reduces prices
and meets high standards of safety and effectiveness.
The new guidelines officially go into
effect 60 days following the FDA’s official notice today.
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