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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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 The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients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.
The guidance document allows patients over the age of 18 to get hearing aids without a medical evaluation. FDA also promised to work on developing a framework for over-the-counter hearing-aid sales. Both elements were included in a bill introduced in the Senate last week.
Following a White House report arguing that the current regulation of hearing aids is stifling innovation and raising costs, FDA has scheduled a gathering to discuss the future of hearing aid regulations. The agency has also reopened a comment period on a pending draft guidance. An industry trade group, however, is skeptical of proposals that have been put forward.