For Immediate Release
January 6, 2016
The U.S. Food and Drug Administration today announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
According to statistics compiled by the National Institute on Deafness and Other Communication Disorders (NIDCD), 37.5 million adults aged 18 and older in America report some form of hearing loss. However, only 30 percent of adults aged 70 and older and 16 percent of adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them. NIDCD is part of the National Institutes of Health.
“The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”