OTC Deregulation and Consumer Self-Fitting Apps
#1The FDA's August 2022 OTC hearing aid rule (effective October 2022) created a new regulatory category allowing adults with perceived mild-to-moderate hearing loss to purchase hearing aids directly without any medical evaluation, audiologist involvement, or prescription. Devices from Bose (SoundControl), Sony (CRE-10, CRE-20), Jabra (Enhance), Philips HearLink, and others entered retail channels including Best Buy, Costco, CVS, and Amazon at price points of $200–$1,600 — a 70-90% discount to prescription-channel equivalents. These devices incorporate smartphone audiometry and AI self-fitting that are validated in peer-reviewed literature (Ear and Hearing, JAMA Otolaryngology) as producing comparable outcomes for mild-to-moderate loss relative to specialist-fitted prescription devices.