|
 White House spokeswoman Jen Psaki said the proposed rules should be
finalized next year and should increase competition to drive down
prices, so the devices cost "hundreds instead of thousands of
dollars."
The changes "will help millions of Americans with mild to moderate
healing loss get access to cheaper and more convenient access to
hearing aids," she told reporters, adding just one-fifth of the
estimated 37.5 million Americans who have trouble hearing use such
aids.
The rule allows greater reach to communities of color that have been
typically lacked access to hearing aids, said Xavier Becerra,
secretary of Health and Human Services.
Under the proposal, hearing aids for severe hearing loss or for
users younger than 18 would remain as prescription devices.
The department will take comments on the proposed rule for 90 days
and plan to implement the rule 60 days after finalizing it.
"Finalizing this remains a top priority for the agency," said Jeff
Shuren, director of the FDA's Center for Devices and Radiological
Health, said during a press call.
[to top of second column] |
 Representative Debbie Dingell
called the announcement "a major step forward
for hearing health and will increase the
accessibility of affordable hearing aid options
for those who need them."
The proposed rule follows an instruction in
President Joe Biden's broad competition
executive order, which had told the Department
of Health and Human Services to "promote the
wide availability of low-cost hearing aids,"
among many other instructions aimed at a wide
variety of industries.
(Reporting by Manojna Maddipatla in Bengaluru
and Diane Bartz and Trevor Hunnicutt in
Washington; Editing by Shinjini Ganguli and Nick
Zieminski)
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