For the 37.5 million adults who have trouble hearing without a hearing aid, Bose has a new product for you. The U.S. Food and Drug Administration today approved audio technology company Bose to market a new hearing aid device.

Dubbed the Bose Hearing Aid, it’s designed to let people with audio impairments fit, program and control the hearing aid without the help or assistance of a healthcare provider. The hearing aid uses air conduction to capture sound vibrations through the microphone. From there, the device processes the signal, amplifies it and then plays it back through an earphone inside the ear canal. Through a mobile app, people can adjust the hearing aid.

“Hearing loss is a significant public health issue, especially as individuals age,” Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said in a press release. “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. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

Before approving the device for marketing, the FDA says it reviewed data from clinical trials of 125 patients. Those studies showed comparable results to those with professionally fitted devices.

“In addition, when participants self-fit the Bose Hearing Aid, they generally preferred those hearing aid settings over the professionally-selected setting,” the FDA wrote in a blog post.

Bose is not the first company to try this. The now-defunct startup Doppler Labs developed earbuds with active listening, enabling people to augment the way they heard the world. There’s also Nuheara, which unveiled earbuds earlier this year that are designed to boost hearing. What makes Bose’s different, however, is the FDA approval.

Bose went through the FDA’s De Novo premarket review process, which is a regulatory pathway for low to moderate-risk devices that are especially novel, and not already available. As the FDA mentioned, this is the first hearing aid authorized for marketing that enables people to fit and program their own hearing aids. Still, depending on state laws, people may be required to purchase the device through a licensed hearing aid dispenser.

It’s not clear what this device looks like, or if the Bose Hearphones — currently marketed as a “conversation-enhancing” headphone — will simply be remarketed as a hearing aid.

“Bose has been delivering industry-leading audio experiences for over 50 years, and more recently we’ve applied that expertise to help people hear better in noise,” Bose spokesperson Joanne Berhiaume told TechCrunch in a statement. “Now, the De Novo grant by the FDA 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.”



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