ASHA Representatives, Other Stakeholders, Advise FDA on Hearing Aid Regulations

Should a recent national report on hearing aids affect federal regulations and guidance on the devices? That was the focus of a Thursday gathering of ASHA and other hearing-related organizations and companies, as well as clinicians and consumers. The site of the discussions was the U.S. Food and Drug Administration’s (FDA) campus in White Oak, Maryland, outside Washington, D.C.

Neil DiSarno, ASHA Chief Staff Officer for Audiology (left), presented at the FDA session on April 21.

The public workshop “Streamlining Good Manufacturing Practices for Hearing Aids” focused on a recent report from the President’s Council of Advisors on Science and Technology (PCAST) examining accessibility and technology in hearing health care. The report recommended the withdrawal of a 2013 FDA guidance on personal sound amplification products (PSAPs), which states they are not intended for people with hearing loss, as well as the creation a new class of over-the-counter (OTC) hearing aids that would be available without professional examination or rehabilitation.

Consumers with hearing loss should know they need to work with an audiologist, not just a device, to “address the multifaceted, disabling effects of this chronic health condition,” said ASHA Chief Staff Officer for Audiology Neil DiSarno in his presentation, which highlighted the importance of counseling for all patients with hearing impairments, especially children.

He also urged the FDA to continue to “distinguish between medical devices [hearing aids] and consumer electronics,” such as PSAPs.

DiSarno—along with 11 other experts from associations, manufacturers and companies—sat on the workshop’s invited panel sessions, which covered hearing aid access, the PCAST report’s proposal to stratify hearing-aid classifications, and quality standards for manufacturing devices.

Earlier in the day, speakers from the public addressed the audience, expressing varying degrees of support or opposition to the PCAST recommendations. Some, such as Jay Ronquillo, director of biomedical informatics at the National Center for Health Research, cautioned the FDA in heeding the PCAST recommendations, pointing out a lack of research on PSAPs and OTC hearing aids.

“We urge you to recommend medical or clinical guidance” for consumers who use these products, Ronquillo said. Additional presenters who opposed the PCAST report also stressed potential risks of PSAP use, including harmful levels of gain available in some models.

Others at the meeting, including audiologist Gail Gudmundsen, argued that the FDA needs to ease regulations and definitions of these devices—including the withdrawal of the 2013 guidance on PSAPs—because of their potential to increase access for people with hearing loss.

“Consumers are smarter than we realize,” she said, adding that they will be able to make informed decisions about their hearing health care.

Additional speakers included representatives from the Hearing Loss Association of America, the Academy of Doctors of Audiology, the American Academy of Audiology, the American Academy of Otolaryngology–Head and Neck Surgery, the International Hearing Society, the Consumer Technology Association, the Hearing Industries Association and the Acoustical Society of America.

The FDA’s draft guidance is open for public comments through May 19.

For more information, read ASHA’s original response to the PCAST report from then-president Judith L. Page and check out the Leader’s January feature on PSAPs.

Haley Blum is a writer/editor for The ASHA Leader. hblum@asha.org