Trade Groups Protest OTC, QSR-Exempt Hearing Aids At FDA Meeting
This article was originally published in The Gray Sheet
Physicians and manufacturers alike expressed serious concerns with a proposal from White House advisors to make some hearing aids available over-the-counter and exempt from the Quality System Regulation at a recent FDA workshop. They argue the plan could endanger consumers without significantly lowering device costs.
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One of 72 items in an executive order by the president on promoting competition in the economy notes that 14% of the around 48m US consumers with hearing loss use hearing aids because, on average, they cost more than $5,000 per pair, costs often not covered by health insurance.
The Biden administration wants to make hearing aids less expensive and more readily available – and seeks the same for internet service and prescription drugs.
The US Federal Trade Commission plans to discuss hearing-aid marketing rules at an April 18 workshop. The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients with hearing loss from getting help.