Bose receives FDA approval for its new hearing aid

Bose's latest tech development, the Bose Hearing Aid, aims to offer users the power to control their hearing aid settings based on their needs


Bose's latest tech offering, the Bose Hearing Aid, has received the US Food and Drug Administration (FDA) seal of approval to market its new product to those with hearing impairments.

According to the FDA, the new hearing aid is the first of its kind to get the FDA's seal of approval which aims to enable "users to fit, program and control the hearing aid on their own, without assistance from a health care provider".

"Approximately 37.5 million adults aged 18 and over report having some trouble hearing without a hearing aid, ranging from "a little trouble" to "deaf," the FDA added.

The FDA's director of the ophthalmic and ear, nose & throat devices division, Malvina Eydelman said: "Hearing loss is a significant public health issue, especially as individuals age. Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device.

"The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care," she noted.

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The new hearing aid technology comprises of a user-fitted wireless conduction to capture sound vibrations through integrated microphones, while offering users the power to control adjustments based on their needs in real time via a mobile application.

Prior to the approval, the FDA reviewed data derived from the clinical study of 125 patients. The FDA stated it had outlined the benefits of a self-fitting aid in comparison to prescribed aids saying, "with respect to the amount of amplification selected, speech in noise testing and overall benefit."

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