OTC Hearing Aids and Nuance Audio Glasses: Innovation & Outcomes 2026

Over-the-counter (OTC) hearing aids were approved by the Food and Drug Administration (FDA) on October 17, 2022. Two primary reasons the FDA approved OTC hearing aids were to make hearing aids more affordable/less expensive and to make these products more accessible.¹ The FDA approved OTC hearing devices for adults with perceived mild-to-moderate hearing loss and for whom there were no medical contraindications.² OTC hearing aids quickly settled into online and retail locations across the United States. However, since 2022, some OTC manufacturers exited the market, some joined forces, some relabeled their products, and many creative OTC products entered the market. Hearing and Listening Demographics The demographics of the hearing healthcare marketplace remain staggering. Based on a population of some 342 million people in the USA,³ estimates indicate 73 million people have hearing loss⁴ and an additional 26 million Americans have no audiometric hearing loss but have hearing difficulty and speech-in-noise (SIN) complaints.⁵ SIN complaints are common and may be referred to as “sub-clinical,” “central,” or “auditory processing” issues. This would suggest that approximately 100 million people in the United States have hearing and/or listening problems. That’s almost 1 in 3 people. In a recent study, Humes⁶ reported 85-90% of those with mild-to-moderate hearing loss have an unmet need for hearing healthcare, resulting in approximately 58-60 million people who may be candidates. Why Hearing Screenings Cannot Replace Audiometric Comprehensive Evaluations Harel-Arbeli & Beck⁷ recommended audiometric comprehensive evaluations (ACE) by a licensed hearing care provider for individuals concerned about their own or a loved one’s hearing health. The authors stated hearing health is crucial for numerous life metrics,