FDA clears self-fit hearing aid controlled by patients via app

The Food and Drug Administration has approved a hearing aid that enables patients to fit, program and control the device without the help of a healthcare provider.

Users of the Bose Hearing Aid from Bose Corporation can make adjustments via a mobile app on their smartphones, enabling them to adjust the hearing aid settings in real time and in real-world environments without medical assistance, according to the FDA.

“Hearing loss is a significant public health issue, especially as individuals age,” says Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. He noted that the regulatory agency’s authorizing of the marketing of the Bose device “provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device.”

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According to the FDA, about 37.5 million adults age 18 and older report having some trouble hearing without a hearing aid. The new Bose device, which is designed to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss, is a user-fitted wireless air conduction hearing aid that works by capturing sound vibrations through one or more microphones.

As part of the FDA’s De Novo premarket review pathway, the agency reviewed data from clinical studies involving 125 patients; the study showed 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.”

Further, the agency stated that patients who self-fit the Bose Hearing Aid generally preferred those hearing aid settings over the professionally selected settings.

Although users may fit, program and control the Bose Hearing Aid on their own, the FDA points out that 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.”