The FDA is looking to stakeholders for input on how to overcome barriers to access and spur the development of hearing aids — devices that often are underutilized by hearing-impaired people.
The agency has scheduled an April 21 public workshop to outline the FDA’s perspective on current good manufacturing practices required under its Quality Systems Regulation and to seek comment on alternative models for regulating hearing aids.
In addition, the agency is reopening a public comment period on draft guidance that clarifies the difference in regulatory requirements between hearing aids and personal sound amplification products —wearable electronic products for use by non-hearing-impaired individuals to amplify sounds in certain environments.
The FDA’s efforts follow an October 2015 report from the President’s Council of Advisors in Science and Technology recommending possible modifications to FDA regulations that “could dramatically enhance the pace of innovation and level of competition in this domain,” encouraging cost reductions and improved capability and convenience.
The draft guidance states that hearing aids are medical devices subject to GMPs and other QSR requirements. However, PSAPs are considered electronic products, as opposed to medical devices, and the document states that manufacturers should not use product labeling or promotional materials to suggest that hearing impaired consumers should use them.
More than 35 million people in the U.S. have some degree of hearing loss, but only 20 percent of those who could benefit from hearing aids are using them. The FDA says the devices are underutilized due to their high cost and the perceived stigma associated with using them.