FDA Allows Sale of Self-Fitted Hearing Aid

"Hearing loss is a significant public health issue, especially as individuals age," said Dr. Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at 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 U.S. Food and Drug Administration is allowing the sale of a new device, the Bose Hearing Aid, that is intended to amplify sounds for individuals 18 or older with perceived mild to moderate 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 Dr. Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at 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."

About 37.5 million adults report having some trouble hearing without a hearing aid. Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions, and other factors, and it 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.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Patients can adjust the device through a mobile app on their phone. The technology enables users to fit the hearing aid settings themselves, in real time and in real-world environments, without needing 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. 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.

The agency's announcement said in authorizing marketing of the Bose device, 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. Participants who self-fitted the Bose Hearing Aid generally preferred those hearing aid settings over the professionally selected settings, it said. The Bose Hearing Aid was reviewed under 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.

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