FDA Approves Marketing of First User-Fitted Hearing Aid
TUESDAY, Oct. 9, 2018 -- The first hearing aid that does not require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.
The Bose Hearing Aid is a user-fitted device for people aged 18 and older with mild-to-moderate hearing loss, the agency said in a news release.
The Bose device was evaluated in clinical studies involving 125 people. When participants self-fitted the device and used a cellphone app to program and adjust the device settings, they "generally preferred those hearing aid settings over the professionally-selected settings," the FDA said. While users can fit, program, and control the device on their own, some state laws require that hearing aids be obtained from a licensed dispenser.
"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," Malvina Eydelman, M.D., director of the FDA's Division of Ophthalmic, and Ear, Nose and Throat Devices, said in a statement.
Bose Corp. is based in Framingham, Mass.
© 2019 HealthDay. All rights reserved.
Posted: October 2018