The FDA issued new guidance immediately removing a requirement for people over 18 to receive a medical evaluation or sign a waiver before purchasing most hearing aids and opens doors for the creation of a new over-the-counter category of hearing aids.
Eric Mann, clinical deputy director of the Division of Ophthalmic and Ear, Nose, and Throat Devices at the Food and Drug Administration (FDA), announced the new guidance at a meeting on hearing health care in adults at the National Academies of Sciences (NAS) in Washington, D.C., on Wednesday morning.
The regulatory agency stated its “commitment to consider creating a category of over-the-counter (OTC) hearing aids” that would not require the consultation of a licensed dispenser, which the FDA says would increase the affordability and accessibility of hearing aids for consumers. The FDA will consider recommendations from previous reports by the NAS as well as the President’s Council on Science and Technology (PCAST), which support OTC hearing aids and regulatory changes.
“While ASHA supports greater access to technology, we continue to maintain that counseling and aural rehabilitation—provided by audiologists—are critical to the successful adaptation of technology,” an ASHA announcement about the new FDA guidance said. “ASHA is also concerned that, although the FDA will still require a medical evaluation for children, there is nothing to stop a parent from purchasing an OTC device for their child with hearing loss without consultation from a hearing health care professional. We have formally commented that children treated with these devices are at risk for severe complications due to untreated ear disease and/or inadequate amplification.”
ASHA has presented publicly to the FDA and has provided formal comments that oppose these regulatory changes.
Haley Blum is a writer/editor for The ASHA Leader. firstname.lastname@example.org