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US FDA allows marketing of first self-fitting Bose Hearing Aid.

M2 EQUITYBITES-October 8, 2018-US FDA allows marketing of first self-fitting Bose Hearing Aid


Public health agency the US Food and Drug Administration announced on Friday that it has approved the marketing of the new Bose Hearing Aid device intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss), which can be caused by ageing, exposure to loud noises, certain medical conditions and other factors.

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

In conjunction, the new Bose Hearing Aid device is reportedly the first hearing aid authorised for marketing by the US FDA that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider.

According to the agency, the Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, which works 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, without the assistance of a health care professional.

Under the US FDA De Novo premarket review pathway, the agency 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 Bose Hearing Aid has been labelled to inform the consumer when to consult a hearing health care professional.

However, the new Bose Hearing Aid device must comply with 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, concluded the agency.

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Publication:M2 EquityBites (EQB)
Date:Oct 8, 2018
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