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FDA approves direct-to-consumer hearing aid from Bose
The US Food and Drug Administration has, for the first time, approved a hearing aid that can be fit, programmed and controlled by the user instead of a healthcare provider. The device comes from Bose and users can make adjustments to its settings in real time through a mobile app. "Hearing loss is a significant public health issue, especially as individuals age," said Malvina Eydelman, 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."
