Today, Sens. Chuck Grassley (R-Iowa) and
Elizabeth Warren (D-Mass.) introduced new legislation that would require the
Food and Drug Administration (FDA) to issue a final rule regarding
over-the-counter hearing aids. Their bipartisan Delivering Over-the-Counter Hearing Aids Now Act follows the FDA’s
proposed rule implementing over-the-counter hearing aids in October 2021, which
was issued more than a year after the statutory deadline and over four years
after the law’s passage. This bill would apply additional pressure on FDA to
finalize the rule, requiring the agency to issue a final rule within 30 days
following enactment. In July 2021, President Biden signaled his support for
over-the-counter hearing aids in his Executive Order on Promoting Competition
in the American Economy.
“I hear from Iowans all the time about
the high cost of hearing aids – sometimes as high as $10,000. These prices are
often shocking for seniors on a fixed income. Our bipartisan proposal will
build on the important work we’ve already done to ensure that 38 million
Americans who suffer from hearing loss have access to high-quality, affordable
hearing aids,” Grassley said.
“Almost five years ago, Senator Chuck
Grassley and I passed our bipartisan bill to allow hearing aids to be sold
over-the-counter, but the FDA has yet to finalize the rule to implement it.
This rule is long overdue, and the FDA needs to act with urgency – not buckle
to the pressure of corporate interests – to finalize a strong rule that will
increase competition, lower costs for consumers, and ensure that people can
finally buy hearing aids right off the shelf," Warren said.
In 2017, Congress passed
the FDA Reauthorization Act, which
included Grassley’s and Warren’s
Over-the-Counter
Hearing Aid Act, requiring 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.
More than 38 million Americans experience some degree of
hearing loss. Older Americans are particularly affected, with nearly
half of adults 75 or older
reporting difficulty hearing. Despite the prevalence of hearing
loss, only one in five people who could benefit from a hearing aid use one,
mainly due to high costs. Hearing aids are not generally covered by private
health insurance plans or traditional Medicare and can cost thousands of
dollars – making them prohibitively expensive for many Americans.
Grassley’s and Warren’s
Over-the-Counter
Hearing Aid Act
removes outdated regulations that block consumer access to affordable hearing
aids, and it 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.
Additional
original cosponsors of the legislation include Sens. Maggie Hassan (D-N.H.) and
Marsha Blackburn (R-Tenn.).
-30-