Oct. 5, 2018 -- The FDA on Friday approved the sale of the first hearing aid that users can buy, fit, and use themselves, without the sometimes expensive expert help.
The Bose Hearing Aid is for anyone 18 and older with mild to moderate hearing loss.
“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,” 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. “The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”
More than 37 million adults have some level of hearing loss.
The wireless Bose Hearing Aid is what’s known as an “air conduction” hearing aid. These devices capture sound vibrations through one or more microphones. The signal is then processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through an app on their phone. This technology lets users choose the hearing aid settings themselves.
In a statement, Bose says the FDA approval "validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids, but don’t use them."
Some state laws may still require the hearing aid to be purchased from a licensed dealer.
The FDA’s decision is part of a move toward greater consumer freedom when it comes to hearing aids. The FDA Reauthorization Act of 2017 requires the agency to write new regulations for over-the-counter hearing aids.
The FDA says it reviewed data from clinical studies of 125 patients that showed the Bose device is comparable to a professionally fitted hearing aid.