Electronics producer Bose Corp. has been granted approval by the U.S. Food and Drug Administration for a first-of-its-kind "self-fitting" hearing aid for adults with mild to moderate hearing loss.
The FDA approved marketing of the Bose Hearing Aid on Oct. 5, marking the approval of the first hearing aid device that allows users to install, integrate and adjust it without help from a healthcare provider or professional.
Approval for the device is based on data from clinical studies that found the results of the self-fitting device were similar to fittings conducted by a professional. The device uses wireless air conduction hearing aid technology, capturing sound vibrations through one or more microphones, which can be adjusted through a mobile application on a phone.
The U.S. regulator reviewed the device under its de novo premarket regulatory pathway, which is for novel, low- to moderate-risk devices.
"Today's marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device," said Malvina Eydelman, director of the division of ophthalmic, and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health.
The FDA said in its Oct. 5 press release that due to federal and state laws the hearing aids may only be available from a licensed hearing aid seller. But the U.S. watchdog is presently drafting regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.
The FDA also said in its press release that about 37.5 million adults 18 years and older face hearing problems without a hearing aid, ranging from "a little trouble" to deafness.