Self-Fitting Hearing Aid Receives Nod from FDA

A newly-approved device could change the way patients manage their hearing loss. Last week, FDA greenlit the Bose Hearing Aid, which is called the first such technology that doesn’t require the assistance of an audiologist or healthcare providers. The hearing aid was developed by Framingham, MA-based Bose Corp., and is intended to amplify sounds for individuals 18-years or older with perceived mild to moderate hearing impairment (hearing loss.) “Hearing loss is a significant public health issue, especially as individuals age,” Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health, said in a release. “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. FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.” The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. The signal is processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to f...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news