New Self-fitting Hearing Aid Class and Special Controls Described by FDA Letter


Am I reading this right? It sounds like “self-fitting hearing aids” can be just like normal hearing aids (more powerful than upcoming class of OTC aids)…

The new Class II self-fitting classification within hearing aids should not be confused with the still-to-come Over-the-Counter (OTC) Hearing Aid classification that FDA is developing. The OTC Hearing Aid Act was passed by Congress and signed into law by President Trump in August 2017 as part of the FDA Reauthorization Act of 2017 (FDARA). It is designed to provide better affordability and accessibility for adults with perceived mild-to-moderate hearing loss, and give them access to OTC hearing aids without being seen by a hearing care professional. In contrast, the new Class II self-fitting device—the Bose Hearing Aid being the first example—is a hearing aid within the “traditional” Class I (for non-wireless air conduction hearing aids) and Class II (for wireless air-conduction and bone conduction hearing aids) medical device categories as established by FDA.



Sure sounds like it. Companies like Bose, Apple, Sony, Samsung, etc. have a huge advantage in this arena in terms of pricing, name recognition, marketing smarts, customer service (which is truly awful with the big 6), etc. I suspect the next five years will cause an enormous amount of disruption for traditional HA manufacturers.


It sure sounds that way, but maybe the “controls” are such that it would only be useful for mild to moderate loss (gain and mpo restrictions?)

But it sounds like it could have all the normal bells and whistles.


Got a little more info