Federal Trade Commission Plans Workshop To Address Hearing-Aid Regulations
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 The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients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.
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Most stakeholders speaking and participating in panels during the Federal Trade Commission’s April 18 workshop on hearing aids expressed support for over-the-counter sales of the devices, though several expressed reservations about how to best protect patients.
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.
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.