> I'm a bit surprised Apple hasn't done something; they could really clean up here.
https://www.cell.com/iscience/fulltext/S2589-0042(22)01708-4 (their current devices are almost there)
My guess is they do enter the OTC space within the next year or so or in true Tim Cook fashion just sell a higher binned version of airpod with OTC hearing aid capability. Their watch series 4 already has FDA medical device certifications.
As for the rest of the market, the amount of margin has been insane for hearing aids. I say look at IEM market which uses same balanced armature technology: They charge at a minimum 20x what Knowles charges for the drivers. Chinese sellers figured it out and sell IEM's with the same drivers and only 3-4x markup. It's killed all but the highest custom end of IEM markets (most of the companies merged).
Hearing aids once again have the same balanced armature drivers and mark up at least 200-500x the driver cost. There is of course some cost to the DSP and paying someone to customize it but most of it is pure regulatory capture to get the FDA approval.
