In Industry First, FDA Allows Marketing of Self-Fitting Hearing Aid Controlled by User

October 5, 2018

The U.S. Food and Drug Administration (FDA) announced today that it is allowing the marketing of a new hearing device from Bose. According to the announcement, the Bose Hearing Aid is intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing  loss.

The announcement represents the first time a hearing aid has been authorized for marketing by the FDA that allows end 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. 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.”  –Malvina Eydelman, M.D., director of the Division of Ophthalmic and ENT Devices at the FDA’s Center for Devices and Radiological Health. 


FDA Review and OTC Hearing Aids


The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Users are able to adjust the hearing aid through a mobile application on their phone, and this technology enables the wearer to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a hearing care professional or other healthcare provider.

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 currently in the process of drafting proposed regulations for a new category of over-the-counter (OTC) hearing aids as required by the FDA Reauthorization Act of 2017.

In authorizing marketing of the Bose device, the FDA reportedly 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, it was found 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, which is 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.


Source: FDA

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