OTC Hearing Aids: Evolution, Current Evidence, and Real-World Use

Over-the-counter (OTC) hearing aids have introduced a fundamental change in hearing healthcare by shifting part of the rehabilitation pathway from a predominantly clinician-mediated model toward direct consumer access. Established as a distinct regulatory category in the United States in 2022, OTC hearing aids were designed to reduce persistent barriers related to cost, accessibility, service availability, and delayed help-seeking among adults with perceived mild-to-moderate hearing loss. Their emergence has expanded access to amplification while also redefining questions of candidacy, clinical oversight, and professional support.

This presentation critically examines the evolution of the OTC hearing aid model, current evidence for effectiveness, and the factors influencing successful real-world use. Available studies indicate that appropriately selected adults can achieve meaningful communication benefit from high-quality self-fitting hearing aids, with some controlled trials reporting outcomes comparable to professionally fitted devices. However, these findings should not be interpreted as evidence of universal equivalence. Current evidence remains concentrated on a limited number of devices, selected populations, and predominantly patient-reported outcomes, while considerable variability persists across products, users, and service models.

Successful OTC use depends on more than access to amplification. Users must be able to select an appropriate device, achieve an adequate physical and acoustic fit, manage setup and maintenance, evaluate everyday benefit, and recognize when self-directed care is insufficient. Medical warning signs, complex or asymmetric hearing difficulties, poor speech recognition, and limitations in manual, visual, cognitive, digital, or health-literacy abilities may substantially influence candidacy and required support.

OTC hearing aids are therefore best understood not as a replacement for audiological care, but as an additional entry point within a stepped, person-centred model of hearing care. Audiologists remain essential for candidacy assessment, verification, counselling, rehabilitation, troubleshooting, and escalation of care. The key clinical question is no longer simply whether OTC hearing aids can work, but for whom they work, under what conditions, and with what level of support.