Bose over-the-counter hearing aid gets FDA approval

Brittany A. Roston - Oct 5, 2018, 8:06 pm CST
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Bose over-the-counter hearing aid gets FDA approval

The Food and Drug Administration has approved a Bose over-the-counter hearing aid product, enabling the company to start marketing the device in the United States. Simply referred to as the Bose Hearing Aid, this device is the first of its kind that is self-fitting, controlled by the user, and approved for marketing in the US.

The Bose Hearing Aid is described as a wearable device intended for use with adults ages 18 and over. The device is capable of correcting “mild to moderate” hearing loss, meaning it won’t work for all customers. However, for those who only need some help with hearing, the device is an option that doesn’t require going through insurance companies or doctors.

The user is intended to fit the device, program it, and control it themselves. The wearable is wireless and works via air conduction, capturing vibrations from sounds using microphones, then processing, amplifying, and playing them for the user. The device is controlled using a mobile app.

Thanks to this technology, the user can adjust the hearing aid’s settings whenever they want. In describing its approval of the device, the FDA said in a statement:

In authorizing marketing of the Bose device, the FDA 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. In addition, when participants self-fit the Bose Hearing Aid, they generally preferred those hearing aid settings over the professionally-selected settings.

SOURCE: FDA


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