New FDA Guidance Allows Easier Hearing-Aid Access
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.
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House To Link Inspections, 3rd-Party Servicer, OTC Hearing Aid Bills To User-Fee Train
A House Health subcommittee wants to attach a quartet of medtech bills to a fast-moving user fee package in Congress. The bills, which got a hearing before the Energy and Commerce Committee Health Subcommittee May 2, would streamline inspections and third-party certifications of device exports, refine FDA regulations on over-the-counter hearing aids, make third-party device equipment servicers register and file complaints with the agency, and clarify FDA product-center jurisdiction for contract agency-dependent imaging equipment.
Stakeholders Support OTC Hearing Aids At FTC Summit
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.
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 The workshop joins other recent government efforts, including a Senate bill and a US FDA draft guidance document, to grapple with a 2015 report by the President’s Council of Advisors on Science and Technology that found cost and regulations blocked many patients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.