Yet another reason for extreme healthcare costs...
Back when I last read about it, they had a lot of testimonies about people finding the $300 "hearing amplifiers" superior to their $5k "hearing aids". Can't call them "aids" of course, or the FDA gets to step in. Especially as they can setup their devices in a real-world environment and re-adjust as necessary.
Plus, without the FDA in the loop, the unregulated devices are free to develop and deploy new features at a far faster rate - meaning not only are officially approved aids an order of magnitude more expensive, they're a decade or so behind the loop development wise. And that's before you cripple features like bluetooth app configuration because, by golly, you have to have a medical professional doing the setting!