Effectiveness of Over-the-Counter Hearing Aids Versus Professionally Fitted Devices: A Systematic Review and Meta-analysis.

Abstract

To systematically review and meta-analyze the clinical effectiveness of self-fitting over-the-counter (OTC) hearing aids compared with professionally fitted devices. PubMed, Scopus, Web of Science, Food and Drug Administration (FDA) 510(k) and De Novo databases, and ClinicalTrials.gov were searched in March 2025 and updated in August 2025. Reference lists were screened, and manufacturers were contacted for unpublished data. Two reviewers conducted screening, full-text review, and risk-of-bias assessment. Eligible studies were field trials comparing FDA-cleared self-fitting OTC hearing aids or software with audiologist-fitted prescription devices in adults. A random-effects meta-analysis using Hedges' g was performed. Risk of bias was evaluated with RoB 2 and ROBINS-I, and certainty of evidence with GRADE. From 712 records, 24 were included, representing 15 unique studies with 774 participants (739 analyzed). Most were short-term field trials (10 days to 8 weeks) comparing self-fitting and professional fittings of the same device. Pooled analyses showed no significant differences between groups for the Abbreviated Profile of Hearing Aid Benefit (Hedges' g = -0.05; 95% CI, -0.19 to 0.09), Speech, Spatial and Qualities of Hearing Scale - 12 (g = 0.01; 95% CI, -0.33 to 0.36), International Outcome Inventory for Hearing Aids (g = 0.12; 95% CI, -0.35 to 0.59), and Quick Speech-in-Noise test (g = 0.03; 95% CI, -0.22 to 0.28). Risk of bias was moderate to high, and certainty of evidence was low. Based largely on patient-reported measures, self-fitting OTC hearing aids provide outcomes comparable to professionally fitted devices. Larger, independent trials within standard clinical pathways are warranted.