FDA approves first self-assisted hearing aid device

Published: October 06, 2018 14:20:02 | Updated: October 12, 2018 13:37:10


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The United States Food and Drug Administration (FDA) on Friday allowed the marketing of a new hearing aid device that can amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss.

It is the first hearing aid approved by the agency that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

Hearing loss, permanent or temporary, can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, according to FDA.

Air conduction hearing aids can capture sound vibrations through one or more microphones and 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 health care professional, reports Xinhua.

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device 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.

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