The Bose Hearing Aid gives similar results with self-fitting to hearing aids fitted by a health provider.
The U.S. Food and Drug Administration considers hearing loss to be a significant public health issue given the aging population in the country. It is estimated that over 37 million adults have some level of hearing difficulty.
The agency is developing regulations for a new category of over-the-counter hearing aids, as required by the latest reauthorization of the FDA’s user fee agreements passed in 2017.
In the meantime, it recently granted de novo clearance to the Bose Hearing Aid, an over-the-counter hearing aid that users can fit, program and control on their own. The first OTC hearing aid granted FDA clearance, the device is a wireless amplifier placed in the ear canal that can be adjusted by the user through a smartphone app.
The FDA clearance was based on results of a clinical trial with 125 patients. The outcomes obtained for the self-fitted Bose Hearing Aid were similar to those for hearing aids fitted by a healthcare professional. Patients also reported that they were happier with the settings when they fitted the hearing aid themselves compared with when a professional selected them.