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First Self-assisted Hearing Aid Device Approved by FDA

by Hannah Joy on Oct 6 2018 12:52 PM

First Self-assisted Hearing Aid Device Approved by FDA
A new hearing aid device has been approved by the US Food and Drug Administration (FDA), which can amplify sounds for individuals 18 years or older who suffer with perceived mild to moderate hearing loss.
It is the first hearing aid //approved by the agency that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider, Xinhua news agency reported.

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.

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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