First Direct-to-Consumer Hearing Aid Receives FDA Clearance
By: Fran Kritz
July 15, 2021
Categories: AAMI News, Medical Device Manufacturers
|Image courtesy of Bose|
Bose may be on customers' shopping lists when looking for smart speakers and headphones. But the Framingham, MA, company has now entered a new area—by offering a direct-to-consumer, “self-fitting” hearing aid that’s received premarket clearance from the FDA.
The Bose SoundControl Hearing Aids is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment, according to the 510(k) application. The Class II device is adjusted by the user, with no preprogramming or hearing test necessary, and is intended for direct-to-consumer sale and use “without the assistance of a hearing care professional.”
Using a smartphone app developed by the company, users can fit, program, and control the hearing aids, called SoundControl, without a professional visit, hearing test, or prescription. According to the company, the devices currently for sale in a limited number of U.S. states (Massachusetts, Montana, North Carolina, South Carolina, and Texas) with availability expanding later this year.
“In the United States alone, approximately 48 million people suffer from some degree of hearing loss that interferes with their life. But the cost and complexity of treatment have become major barriers to getting help,” said Brian Maguire, category director of Bose Hear, in a press release. “The Bose Hear app lets owners set up and customize their SoundControl Hearing Aids… in less than an hour.”
In a clinical study, the self-fitting method resulted “in outcomes not in any way inferior to professional fitting for adults with mild to moderate hearing loss,” according to the 510(k) premarket clearance application. “Based on patient satisfaction and preference reports, subjects in the Self-Fit Group were satisfied with and preferred their own self adjusted settings to the professionally-selected settings.”