OTC Hearing Aid Act eliminates audiologist gatekeeping for mild-to-moderate loss
#1The FDA's August 2022 OTC Hearing Aid final rule created a new regulatory category permitting direct consumer purchase of hearing aids for perceived mild-to-moderate hearing loss without audiologist examination, prescription, or fitting. By Q1 2024, major retail chains (Best Buy, CVS, Walgreens, Walmart) stocked OTC hearing aids from Samsung/JBL, Sony (CRE series), Jabra Enhance, Bose SoundControl, and Lexie Lumen β all priced $200β$1,600 versus $3,000β$7,000 for audiologist-dispensed devices. The market is projected to reach $3.2B by 2027 (Grand View Research). Concurrently, Apple's iOS 18 Hearing Aid feature (September 2024) converts AirPods Pro into FDA-cleared hearing aids for mild-to-moderate loss, instantly placing AI-fitted hearing devices in the hands of an installed base of 1B+ iPhone users.