Bose gets 510(k) FDA clearance for self-fitting air-conduction hearing aid

Bose has finally managed to move into the lucrative space of hearing aids. The company’s filing with FDA was approved last week.

A self-fitting air-conduction hearing aid is a wearable sound-amplifying device that allows users to program their hearing aids.

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The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones.Bose hearing aids

The signal is processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through a mobile application on their phones.

This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

The Bose self-fitting hearing aid includes 12-channel dynamic range compression amplification. The noise reduction feature is continuously active on the device. The hearing aids also feature feedback cancellation, steady-state noise reduction, volume-optimized audio equalization, and a battery life of approximately 10 hours.

According to the FDA filings, the Bose self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment.

The device requires no pre-programming or hearing testing is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

It is unclear when Bose will start marketing these new hearing aids to customers. The company had originally received De Novo clearing in 2019 for hearing aid products.

This will become the first Bose product to meet the OTC (over-the-counter) hearing aids regulation that was passed. As the OTC regulation gets firmed up by the FDA, we are likely to see more established tech companies enter this space for wearables.

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Sudz Niel Kar
I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox. In my day job, I advise Fortune 500 companies with their digital transformation strategies and also consult with numerous digital health startups in an advisory capacity. I'm VERY interested in exploring the digital health and fitness-tech evolution and keeping a close eye on patents, FDA approvals, strategic partnerships, and developments happening in the wearables and digital health sector. When I'm not writing or presenting, I run with my Apple Watch Ultra or Samsung Galaxy Watch and closely monitor my HRV and other recovery metrics.


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