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.

 Technology anxiety and social appearance anxiety as predictors of hearing aid outcomes

Berna Deniz Kuntman

University of Health Sciences, Gulhane Faculty of Health Sciences, Department of Audiology, Ankara, Türkiye

Introduction (background & aim): hearing aid outcomes are influenced by audiological, technological, and psychosocial factors. Technology anxiety may reduce users’ confidence in managing hearing aids, whereas social appearance anxiety may discourage hearing aid use because of concerns about social evaluation and stigma. However, their contribution to patient-reported hearing aid outcomes remains unclear. This study aimed to investigate whether technology anxiety and social appearance anxiety are associated with hearing aid outcomes in adult hearing aid users.

Material & methods: this quantitative, cross-sectional, correlational study was approved by the lokman hekim university scientific research ethics committee (project no. 2026060; decision no. 2026/078; february 25, 2026) and conducted in accordance with the declaration of helsinki. Adult hearing aid users attending the department of otolaryngology were recruited using consecutive sampling. Inclusion criteria were age ≥18 years, hearing aid use for ≥6 months and ≥1 hour/day, mild-to-severe hearing loss, voluntary participation, and absence of cognitive impairment. Participants underwent otolaryngological examination and audiological assessment and completed a demographic information form, abbreviated technology anxiety scale (ATAS), social appearance anxiety scale (SAAS), and international outcome inventory for hearing aids (IOI-HA). The primary outcome was the IOI-HA total score. ATAS and SAAS were examined as independent variables. Spearman correlation and multiple linear regression analyses were performed, with p<0.05 considered statistically significant.

Results: a total of 82 hearing aid users were included. Mean scores were 26.48±9.94 for ATAS, 32.38±13.60 for SAAS, and 27.30±5.78 for IOI-HA. SAAS was moderately and negatively correlated with IOI-HA scores (ρ=−0.550; p<0.001), whereas ATAS was not significantly correlated with IOI-HA scores (ρ=−0.145; p=0.211). In univariate regression analysis, SAAS significantly predicted IOI-HA scores (β=−0.572; p<0.001; r²=0.327). In the multiple regression model including SAAS and ATAS, the model explained 34.4% of the variance in IOI-HA scores (r²=0.344). SAAS remained a significant negative predictor (β=−0.572; p<0.001), whereas ATAS was not a significant predictor (β=−0.076; p=0.169). Older age was positively correlated with technology anxiety (ρ=0.333; p=0.003).

Conclusions: social appearance anxiety, but not technology anxiety, was independently associated with poorer patient-reported hearing aid outcomes. These findings highlight the importance of addressing social appearance concerns in hearing aid rehabilitation and counseling.