I found this Braun hearing aid user manual in the FCC database. (Braun is a P&G brand)
Users-Manual-4770400.pdf (1.7 MB)
Anyone know anything about it?
Paperwork filed with the FDA mentions:
III. PREDICATE DEVICE
Bose SoundControlTM Hearing Aids – 510(k) # K211008
Does this indicate the Braun Clear is really just a Bose SoundControl Hearing Aid?
No, Bose hearing aid is what the self-fitting hearing aid class is based on, so any 510(k) for a self-fitting hearing aid will need to prove it is substantially equivalent to the Bose hearing aid. And in fact, it’s not the SoundControl hearing aid that is the predicate, but the neckloop style hearing aid (similar to Hearphones) that was used to establish the class.
Here’s the 510(k): K212609.pdf (1.1 MB)
Also, some folks are saying this looks like a match to the Soundworld Solutions HD75: HD75 – Self-fitting OTC Hearing Aids – Sound World Solutions
Being a device that uses radio frequencies it needs t be registered with the FCC. This is probably a sample brochure submitted for the required FCC certification, as witnessed by the last page noting the document creating company. Kax is a company that specializes in marketing health related devices.
It will be interesting to see how the smart phone based testing performs.
Look at the 510k to see how the device performs.