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For the 37.5 million adults who have difficulty hearing without a hearing aid, Bose has a new product for you. The US Food and Drug Administration has approved the Bose audio technology company for the placing on the market of a new hearing aid.
Dubbed the Bose hearing aid, it is designed to allow hearing-impaired people to adapt, program and control the hearing aid without the help of a health care provider. health. 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 earpiece inside the ear canal. Through a mobile application, people can adjust the hearing aid.
"Hearing loss is an important public health problem, especially with the aging of the population," said Dr. Malvina Eydelman, Director of the Ophthalmic and Ophthalmological and Ophthalmological Division. . "Today's marketing authorization allows some patients to have access to a new hearing aid that allows them to directly control the fit and functionality of their device. The FDA is committed to ensuring that people with hearing loss have the opportunity to play an active role in their health care. "
Before approving the device for commercialization, the FDA announced it had reviewed clinical trial data from 125 patients. These studies have shown results comparable to those of professionally equipped devices.
"In addition, when participants adapted themselves to the Bose hearing aid, they generally preferred hearing aid settings to professionally selected settings," the FDA wrote in an article. of blog.
Bose is not the first company to try this. Doppler start – up Labs, now gone, has developed active listening earpieces, allowing people to improve their perception of the world. There is also Nuheara, which unveiled earlier this year earpieces designed to improve hearing. However, what differentiates Bose is the FDA's approval.
Bose has followed the FDA's Novo Pre-Market Review process, which is a regulatory procedure for low to moderate risk devices, which are particularly new and not yet available. As mentioned by the FDA, it is the first hearing aid that allows users to adapt and program their own hearing aids. However, depending on the laws in your country, it may be necessary to purchase the device through an authorized hearing aid distributor.
It's unclear what this device looks like, or whether Bose Hearphones – currently marketed as "conversation-enhancing" headphones – will simply be re-marketed as hearing aids.
"Bose has been delivering cutting-edge audio experiences in the industry for over 50 years, and more recently, we have used this expertise to help people hear better in noise," said Bose spokesperson, Joanne Berhiaume, at TechCrunch. "Now, the FDA's De Novo grant confirms that Bose technologies can be applied to help people with mild to moderate hearing loss manage their hearing. We are eager to bring Affordable, accessible solutions that sound good for the millions of people who could benefit from hearing aids but do not use them. "
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