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

To systematically review and meta-analyze the clinical effectiveness of self-fitting over-the-counter (OTC) hearing aids compared with professionally fitted devices. DATA SOURCES: 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....

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Audiologists should be prepared to discuss OTC hearing aid effectiveness with patients — this meta-analysis provides the strongest comparative evidence to date and may inform counseling on when professional fitting adds measurable benefit.

As OTC hearing aids reshape the hearing care market, robust meta-analytic evidence on their comparative effectiveness is critical for guiding patient counseling, policy decisions, and the professional fitting value proposition.

1. 01Systematic review and meta-analysis directly compares OTC self-fitting hearing aids with professionally fitted devices.
2. 02Provides the highest available level of evidence (1a) on a question central to the post-OTC-regulation hearing care landscape.
3. 03Findings have direct implications for audiologists justifying the added value of professional fitting services.
4. 04Results could influence both consumer guidance and healthcare policy regarding OTC hearing aid access.
5. 05Study published in Otolaryngology–Head and Neck Surgery, a high-impact peer-reviewed journal.

PMID

42307981

DOI

10.1002/ohn.70306.

Journal

Otolaryngology–Head and Neck Surgery

Publication type

meta_analysis

Evidence level

1a

Population

Adults with hearing loss using OTC or professionally fitted hearing aids

Intervention

Over-the-counter self-fitting hearing aids

Comparator

Professionally fitted hearing aids