WASHINGTON –
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Hearing Aid Act removes outdated regulations blocking consumer access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.