Bose Wireless earphones

FDA allows marketing of first self-fitting hearing aid controlled by the user

On October 5th,2018, the Food and Drug Administration issued a press release announcing that Bose now had the approval to market a new hearing aid that could actually be self-adjusted without the help of a hearing care professional.

This is a big news in the hearing industry.

Although FDA Reauthorization Act of 2017 (FDARA) was signed into law on August 18, 2017, mentioning to establish a new category of over-the-counter (OTC) hearing aids and the requirements that apply to them, FDA has three years from the time was signed into law in 2017 before they actually establish the criteria for what an OTC hearing aid is and what the regulations will be on those particular devices.

Basically, this means OTC hearing aids don’t exist yet because there is no criteria to define what an OTC HA is.

With the marketing approval of FDA, Bose is getting a massive headstart on the competition ahead of the OTC hearing aid act guidelines going into effect.

Now let’s take a look of what Bose HA may do: Users could adjust the HA through a mobile application. Fit the HA setting by themselves depends on environment. In short, the biggest bright point is “self-fitting”.

Bose has not released their hearing aids yet, we are not able to find hearing aid on their website. Currently, we don’t know what they look like, will they look like a consumer electronics or a HA? As for price, we don’t have a clue either. It’s hard to speculate how good the Bose HAs will be, but it might be a good choice for individuals with mild to moderate hearing loss.

For hearing aid distributor/dispenser, FDA’s marketing approval on Bose HA is a good signal.


Doctor Cliff’s video of Bose Hearing Aid FDA Approval | Self-Fitting Hearing Aid

FDA News Release

Full text of FDA Reauthorization Act of 2017 (FDARA)

OTC HA Letter to Industry_July2018_FINAL

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