Megan Rose Dickey@meganrosedickey October 5, 2018
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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