FDA approves Bose Hearing Aid.-Bose Corporation

The FDA has allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. The FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.

The Bose Hearing Aid was reviewed under the FDA�s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of the Bose Hearing Aid device to Bose Corporation..

The Bose Hearing Aid is designed to let people with audio impairments fit, program and control the hearing aid without the help or assistance of a healthcare provider. The hearing aid uses air conduction to capture sound vibrations through the microphone. From there, the device processes the signal, amplifies it and then plays it back through an earphone inside the ear canal. Through a mobile app, people can adjust the hearing aid.