“…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,” 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
percent 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Hearing Aid Act removes outdated regulations blocking consumer access to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.
Full text of the letter can be found
HERE.
