FDA Allows Sales of First Self-Fitting Hearing Aid
Author: internet - Published 2018-10-04 07:00:00 PM - (387 Reads)The U.S. Food and Drug Administration (FDA) has approved the sale of the first self-fitting hearing aid, reports WebMD . The wireless Bose Hearing Aid is for anyone 18 and older with mild to moderate hearing loss. "Today's marketing authorization provides certain users with access to a new hearing aid that provides them with direct control over the fit and functionality of the device," says Malvina Eydelman with the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA's Center for Devices and Radiological Health. "The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their healthcare." The Bose device is an "air conduction" hearing aid designed to capture sound vibrations through one or more microphones, and then process amplify, and play back the signal through an earphone placed in the ear canal. Users can adjust the hearing aid via an app on their phone, selecting the hearing aid settings themselves. Bose says the FDA approval "validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible, and great sounding solutions to the millions of people who could benefit from hearing aids, but don't use them."