Posted by Michael Wonder on 08 Oct 2018
FDA allows marketing of first self-fitting hearing aid controlled by the user
5 October 2018 - The U.S. FDA 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 authorised 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.
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.
