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Bose’s Hearing Aid Receives FDA Approval

Over-the-counter hearing aid will allow more moderate and mild to moderate patients with hearing problems seek direct control via the device’s mobile app…

[Caption: First over-the counter hearing device by Bose]

[Caption: First over-the counter hearing device by Bose]

The Food and Drug Administration (FDA) has approved the first ever hearing aid — a Bose’s invention — that can be used without the assistance of a medical professional. According to FDA’s report, more than 37 million Americans suffer from hearing loss, which may range in severity from “a little trouble” to “deaf”. Aging, exposure to loud noises and medical condition may cause permanent or temporary damage to one’s hearing.

The best news for Bose so far is that the approval will allow the company to sell the user-friendly, over-the-counter ‘gear’ that can be used without the assistance of a medical professional and will allow users to “fit, programme, and control the hearing aid on their own without assistance from a health care provider,” said Bose in a news release.

Malvina Eydelman, Director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said that the approval of this device should allow patients with mild to moderate hearing issues obtain direct control without the need of a medical professional.

The hearing aid can be controlled through a mobile app to allow users to make adjustments on their own. The device itself is a wireless hearing aid which produce louders sounds by capturing sound waves and amplifying them through the use of microphones. To date, over 125 patients have been tested.

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