I asked Tympan about this, they said they've partnered with Boys Town National Research Hospital and with the National Institute on Deafness and Communication D

I asked Tympan about this, they said they've partnered with Boys Town National Research Hospital and with the National Institute on Deafness and Communication Disorders. Those two powerful partners are working on relaxing the laws some so that small companies/teams could create something like the Tympan. I'm still not sure if the Tympan is a "human use approved hearing aid" or if it's just for research purposes. Hopefully I'll have discovered that before I publish part 2.