Bose, known for its speakers and noise-cancelling headphones, doesn’t just want to make cool audio products anymore.
About a year and a half ago, Bose spun up a health division with an ambitious goal: to use its sound chops to help people with aural medical issues.
“We thought we could make a significant impact in hearing . . . and sleep,” said John Roselli, general manager of Bose Health at CB Insights Future of Health Conference in October.
While Roselli insists that the motivation to get into health was an altruistic one, there is a business case for creating devices for the 37.5 million American adults who suffer some form of hearing loss. The National Institute on Deafness and Communication Disorders estimates that 28.8 million U.S. adults are in need of a hearing aid, which is already a $7.7 billion business in the United States. The advent of over-the-counter hearing aids could grow the business opportunity even further. Bose Health will target these millions of people, not to mention the one in four Americans who periodically can’t sleep. Sleep aids, meanwhile, generate $70 billion in sales.
Though Bose Health debuted 18 months ago, it has long been in the works. In 2014, the company acquired a startup called Ear Machine, which at the time was working with the National Institute of Health to test technology that allowed users to control the settings on their hearing aids through a mobile app (rather than having an audiologist set them). The study tested Ear Machine’s technology on 75 people with hearing loss and showed that it was an effective way for patients to adjust their own hearing aids without needing a doctor.
Bose incorporated that technology into its Hearphones, a $499 consumer-level conversation-enhancing hearing amplifier, which it revealed in 2016. Then, the company went on to seek approval from the Food and Drug Administration for a prospective hearing aid. As others have pointed out, the new hearing aid has a lot in common with the sound-amplifying Hearphones, which are for mild to moderate hearing loss. The main differences seem to be that one is regulated by the FDA and one is not. When the FDA comes up with its requirements for over-the-counter hearing aids before August 2020, Bose will likely have to update its technology to comply.
“Even though your product could perform a lot like an FDA-cleared device,” Roselli said, “if you can’t make a medical claim or make messaging around that in terms of what it does, it becomes really difficult—especially if it’s over-the-counter—to try to reach patients and consumers.” In other words, having that FDA approval would signal to consumers that Bose hearing aids are real medical devices that meet certain safety standards.
Bose’s hearing aid has not yet launched commercially, but it has already garnered important federal approval. In 2018, the FDA granted Bose’s current hearing aid De Novo status, an approval to market novel medical technologies that don’t fit into existing categories. (Bose’s hearing aid is considered “novel” because of its self-fitting features.)
At the same time Bose applied for the FDA application, it lobbied for the Over the Counter Hearing Aid Act, a bipartisan effort that paves the way for the existence of regulated over-the-counter hearing aids and enables people to purchase them without seeing an audiologist. It was signed into law in 2017, giving Bose further room to launch a hearing aid.
Amid its big hearing aid push, Bose also started making headway into sleep tech by acquiring a few other startups. In 2017, it bought Hush, a company that embeds white noise inside of ear buds. It incorporated the Hush technology into its $250 Sleepbuds, which play white noise to drown out nagging sounds. Bose’s Sleepbud’s were recently discontinued on the day Roselli and I spoke, because of battery life issues. However, they may make a come back eventually. Roselli said that over time, he’d like to add three or four other features to the buds that would address other causes of sleeplessness, though he declined to specify further.
The fumble goes to show how difficult a foray into health is—even for a company with academic research chops like Bose. Last year, Bose made another purchase: Project Sync, a company that measures how tone, rhythm, and syncopation impact the body. The startup, which spun out of the MIT Media Lab, was looking at ways that sound could be used to manage pain. Bose initially had big ambitions to address more than just sleep and hearing, Roselli said. “Then we realized it was too much, too big to bite off, because healthcare is very difficult to navigate as I’m finding out,” he said. In the case of Project Sync, the technology fell outside the core ailments Bose was looking to treat. The acquisition was ultimately more about bringing on Project Sync’s talent than incorporating its tech—at least for now.
“I’ve had to learn how to throttle things back a little bit because in the consumer space it’s very fast. If you’re not putting out a new project every year, you’re getting behind,” Roselli said. “In the healthcare space, the clock speeds [are] a little bit different.”
Correction: This story has been updated to include details of Bose’s discontinuation of its Sleepbuds.