Self-fitting OTC hearing aid gets nod

December 13, 2018 0 By FM

The USFDA has cleared the Bose Hearing Aid, a self-fitting hearing aid for individuals 18 years or older with perceived mild to moderate hearing impairment.
This hearing aid enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider.
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 fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a healthcare professional.
In authorizing marketing of the Bose device, the FDA reviewed data from clinical studies of 125 patients, which demonstrated that outcomes with self-fitting of the Bose Hearing Aid are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit, the regulatory agency said announcing the approval.