President Joe Biden will sign an executive order Friday (July 9) that calls for FDA to issue a highly anticipated proposal to establish an over-the-counter category of hearing aids and lay out safety, labeling and manufacturing standards for the devices. FDA already missed its self-imposed deadline for a June release of the proposed rule. Biden gives HHS 120 days to issue the proposal, which the White House asserts could help curb the high cost of hearing aids.
Hearing aids are expensive, the White House says in a fact sheet released Friday. On average, they cost more than $5,000 per pair, and those costs often aren’t covered by health insurance. Consumers must get their hearing aids from a doctor or specialist, which is a major reason why prices are so high, according to the Biden administration. “[T]his requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market,” the White House says.
FDA was supposed to propose a rule last year that would allow hearing aids to be sold OTC, but the Trump FDA failed to meet the August 2020 deadline that was established under the 2017 FDA Reauthorization Act. The agency then said it would release the proposal in December 2020. It also missed that deadline.
In its fact sheet, the Biden administration blasts the Trump FDA for failing to issue the proposal, asserting the Trump administration left millions of Americans without low-cost hearing aid options.
However, the Biden FDA also failed to meet its more recent self-imposed June 2021 deadline for issuing the rule.
The Biden executive order directs HHS to issue the proposed rule, “Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations,” within 120 days. That gives HHS and FDA until November to follow the directive.
Biden’s directive is included in a broader executive order that takes myriad actions to increase competition across the U.S. economy.
“The Order includes 72 initiatives by more than a dozen federal agencies to promptly tackle some of the most pressing competition problems across our economy,” the White House’s fact sheet says. “Once implemented, these initiatives will result in concrete improvements to people’s lives.” -- Beth Wang (bwang@iwpnews.com)
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