Until recently, Framingham audio tech company Bose Corp. was missing a market segment that fits quite naturally with its line of speakers, headphones and noise-masking sleepbuds: hearing aids.
That changed earlier this year, when the privately held company started selling FDA-cleared hearing aids based on proprietary technology to consumers at a cost of $849.95, a price significantly lower than average. Such devices can cost thousands of dollars.
So why did it take so long to Bose — founded in 1964 — to make a business move that sounds almost obvious? Part of the answer lies in the regulatory path that Bose had to face and somehow forge for itself. As medical devices, hearing aids are regulated by the U.S. Food and Drug Administration and usually require an exam or a prescription.
"In order for us to really reach customers directly, we had to blaze a new trail," said Steve Romine, vice president of Bose Hear, in a recent interview. "That has taken, you know, some time and effort."
From de novo to approval
The first step was applying for a so-called "de novo" grant with the FDA, which establishes a new medical device type. The agency approved Bose's application to create a new category of hearing aids called "self-fitting air conduction hearing aids" in 2018.
After that, Bose got to work to further develop its hearing aids, which use a proprietary technology called custom-tune technology. After clinical testings validated that the custom-tune technology worked, the FDA granted clearance to the device as the "first real product that fell into that category that was created by our de novo grants," Romine explained.
The FDA 510K clearance came in May 2021, and Bose started selling its device (named SoundControl) shortly after.
Romine didn't say how much the opening of the new market is expected to benefit Bose's overall revenue, nor how sales are going. But with approximately 15% of American adults (37.5 million) aged 18 and over reporting some trouble hearing, the opportunity is out there.
So is competition, as the FDA is making moves to regulate the new market of over-the-counter, or OTC, hearing aids.
"This past October, the FDA published the draft implementing regulations for over-the-counter hearing aids and we're expecting this new market ... to open up in 2022," Romine said.
"We're selling under that first path we blazed through the de novo in the 510K clearance," he added. "But now, when the OTC regulations go into effect, that's going to widen the path and open the market up to too many others."
