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FDA Gives Approval To Bose For Marketing of Self Fitting Hearing Aid



Today, the FDA announced the approval of the “Bose Hearing Aid”, a new self-fitting hearing aid. Bose has been granted an unprecedented position by the FDA, the FDA has given Bose permission to market their new Bose Hearing Aid as a self-fitting hearing aid. The regulations governing this type of device do not exist and right this minute the over the counter (OTC) hearing aid regulations have not yet been finalized. We spoke in 2016 about initial forays into the amplifier market by Bose in the article "BOSE HearPhones, Hearing Aids?" It appears that Bose has decided to enter the over the counter hearing aid market as soon as possible and the FDA appears to be facilitating them. 

Bose Hearphones Website

The FDA press release follows:

The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

“Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “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.”

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.” Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Hearing loss may be permanent or temporary. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds around them better, enabling them to communicate more effectively with others.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. 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.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. The FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.

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. The Bose Hearing Aid has been labeled to inform the consumer when to consult a hearing health care professional.

The Bose Hearing Aid was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of the Bose Hearing Aid device to Bose Corporation.

In essence, this approval means that Bose can market these devices as hearing aids and they can be purchased in states that allow it. In states that regulate the supply of hearing aids through professionals, the devices will have to be purchased from a professional.

At the time of writing, there were no images or full outlines of what the new Bose hearing aids would be. It is hard to tell from the press release if the devices will be hearing aids as is commonly understood or headphones like their HearPhones devices. As more information becomes available, we will update the article. We have spoken before about our belief that self fitting hearing aids may well be the future of hearing aids in the article "Are Self Fitting Hearing Aids The Future?". 

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Posted by

Geoffrey Cooling

Geoffrey Cooling

LinkedIn Twitter Facebook GooglePlus Amazon Author Page Co Founder geoff@audiologyengine.com
Geoffrey (Geoff, anything else makes him nervous) Cooling is an Irish hearing aid blogger and has been involved with the hearing aid industry for over ten years. He has worked in private practice dispensing hearing aids and as a manufacturer's rep. He has written two books and they are both available on Amazon. He loves technology, passing on knowledge and is legendary for many other things, primarily the amount he curses, his dry and mischievous sense of humour and his complete intolerance of people who are full of themselves. Please feel free to connect with him

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