Med Device Monday- BOSE’s Self-Fitting Hearing Aid

Bose™. You know the name; you blast your music through their speakers, you block out annoying sounds with their noise-masking sleepbuds. And now, they’re making their way into the medical device world! This past month, FDA granted marketing of a new device from Bose: the very first hearing aid that doesn’t require assistance from a healthcare provider. This approval comes after data revealed that the Bose Hearing Aid had comparable outcomes to professionally-fit hearing aids, as well as a patient preference for the Bose Hearing Aid settings over the clinician-set settings.



This new hearing device is approved for individuals 18 years and older who have mild to moderate hearing loss, something that is much more common than you’d probably think. According to this website, there are reportedly around 37.5 million adults in that age range who report having troubles hearing, whether it’s severe or minor. Those with permanent hearing loss have the option to use hearing aids to help hear and communicate better, and the Bose Hearing Aid can do just that, without needing the help and assistance of a clinician. You heard right, Bose Hearing Aids do not require a visit to the healthcare provider, ultimately making this technology even more accessible to patients.

The way that the Bose Hearing Aid works is through air conduction, which captures sound vibrations through microphones. Those vibrations are processed and amplified before being played back through the earphone in the ear canal. With the majority of other hearing aids, they can really only be adjusted manually, but with the Bose Hearing Aids, they can be adjusted through a mobile app on a Smartphone. The mobile technology allows users to personally fit the settings of the hearing aids themselves to fit the various environments they encounter day-to-day all on their own.

Currently, FDA is in the process of creating a new category of over-the-counter hearing aids on account of these new hearing aids from Bose. These hearing aids are yet another innovative technology on an ever-growing list of devices that have been reviewed through the De Novo pathway. Thanks to devices like these, it is becoming clear that the future of medical technology certainly is upon us.



Additional Reading

  1. FDA Press Release

  2. FDA Classification Order

  3. Article by TechCrunch

  4. Bose website