This may be old news to some, but I found this transcript from Janice Lintz in 2016 very interesting given the recent fact that Bose just got a De Novo exemption for their first OTC hearing aid. Well, actually it is not classified as an OTC hearing aid just yet because the FDA needs 2 years to figure that very simple thing out.
Of course, the hearing aid dispensary monopoly also will use that 2 years to lobby hard and convince the FDA that OTC hearing aids are "dangerous" and "not within the consumers best interest". Translation; they are scared to death that FINALLY their lock on overpriced hearing aids will be over. I hope the FDA does the right thing and gives the hearing impaired patient population affordable choices to improve their lives.
https://janicelintz.com/2016/04/22/...d-for-transparency-in-the-hearing-aid-market/
Of course, the hearing aid dispensary monopoly also will use that 2 years to lobby hard and convince the FDA that OTC hearing aids are "dangerous" and "not within the consumers best interest". Translation; they are scared to death that FINALLY their lock on overpriced hearing aids will be over. I hope the FDA does the right thing and gives the hearing impaired patient population affordable choices to improve their lives.
https://janicelintz.com/2016/04/22/...d-for-transparency-in-the-hearing-aid-market/