October 9, 2018

FDA grants approval for Bose hearing aid

Photo | Grant Welker
Bose Corp. headquarters in Framingham.

The first hearing aid authorized for use in the U.S. enabling users to fit, program and control the device on their own will be marketed by Framingham-based Bose Corp.

The device, the Bose Hearing Aid, can amplify sounds for individuals 18 years and older with mild to moderate hearing loss.

The U.S. Food and Drug Administration grant approval for the device on Friday.

According to the FDA, the aid is an air-conduction hearing aid working 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.

The hearing aid can be adjusted through a mobile application on a smartphone.

According to the FDA, the device must comply with state and federal laws regarding the sale of hearing aids, which may require the devices to be purchased from a licensed hearing aid dispenser.

The FDA is drafting proposed regulations for a new category of over-the-counter hearing aids.

The approval of the audio technology company's device comes after a study of 125 patients which demonstrated outcomes with Bose's device are comparable to those with professionally fitted devices.


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