Bose Hearing Aid-FDA approved OTC Medical Device

According to the latest news, Bose hearing aids were born. Let’s take a look at the product and see if there is any shining features.

The Bose Hear app is the first self-tuning mobile app that is clinically proven to provide audiologist-level customization for individuals 18 years of age or older with mild to moderate hearing loss.

Bose hearing aids are currently available for purchase in MA, MT, NC, SC and TX states for $849.95.

Here’s a brief summary of Bose hearing aid performance.

Bose SoundControl™ 
Price$850/pair
Available StatesMA,MT,NC,SC和TX
Programs4
Micdirectional/omnidirectional
Average Gain30dB
Batteryzinc-air 312, non-rechargeable
Wear typeRIC
BluetoothCan’t play music or answer phone calls. Hearing aid parameters can be adjusted via the mobile app BOSEHear.
AdvantageClinically proven self-tuning, providing auditory expert customization; Ongoing support is available via video chat or phone call

Overall, Bose hearing aids are satisfying but not perfect, as they neither support the most mainstream lithium-ion charging nor the streaming audio direct connection that users still crave. The so-called self-adjustment function is indeed a breakthrough. It’s tantamount to audiologist’s fitting service. In addition, as a leading manufacturer of speaker and headphone, BOSE is absolutely trustworthy for its standard manufacturing, sales and after-sales service.

For us hearing aid manufacturers or distributors, the birth of Bose hearing aids is both a challenge and a new opportunity. With the release of BOSE hearing aids, more and more people will realize the importance of hearing loss and the usefulness of hearing aids, and start enjoying the help they can bring to them early.

Although the original plan of FDA to release OTC Hearing Aid Act category hearing aids in 2020 is still inconclusive due to the delay of the epidemic, is it possible that we get a glimpse of the OTC hearing aid standard from the performance of Bose hearing aids?

In terms of acoustic performance, Bose hearing aids do not perform much differently from the hearing aids we make. But its self-adjusting app is something that Chinese hearing aid manufacturers could work on.

As the epidemic gradually gets under control, perhaps we can witness the publish of OTC Hearing Aid Act in late 2021 or early 2022? Looking forward to see the OTC hearing aid bill bring unprecedented opportunities to our industry!

Reference: https://www.bose.com/en_us/products/headphones/earbuds/soundcontrol-hearing-aids.html#v=soundcontrol_hearing_aids_gray

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