Over-the-counter hearing aids and integrated health-monitoring sensors: a review of clinical evidence and implementation

The FDA's 2022 over-the-counter (OTC) hearing aid rule created a new access pathway for adults with mild to moderate hearing loss. Hearing aids have also begun incorporating health-monitoring sensors. This PRISMA-guided narrative review evaluates the clinical evidence for OTC hearing aids and the validation status of health sensors in hearing aids, based on 59 studies identified from PubMed, Scopus, Web of Science,...

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Audiologists should stay informed about OTC hearing aid clinical evidence gaps and emerging sensor integration, as these developments directly affect patient counseling, fitting workflows, and clinic business models.

The FDA's OTC hearing aid rule and the convergence of hearing aids with wearable health technology are reshaping audiology practice, patient access, and the competitive landscape for hearing care.

1. 01FDA's 2022 OTC hearing aid rule allows adults with mild-to-moderate hearing loss to buy devices without a prescription.
2. 02Clinical evidence for OTC hearing aid outcomes relative to professionally fitted aids remains limited.
3. 03Health-monitoring sensors (e.g., fall detection, heart rate, activity tracking) are increasingly integrated into hearing aid platforms.
4. 04Implementation challenges include patient self-fitting accuracy, follow-up care gaps, and data privacy concerns.
5. 05Review findings have direct implications for audiology clinic positioning and patient education.

PMID

42592166

DOI

10.3389/fdgth.2026.1771022.

Journal

Frontiers in Digital Health

Publication type

review

Evidence level

5

Population

Adults with mild-to-moderate hearing loss eligible for OTC hearing aids

Intervention

Over-the-counter hearing aids with and without integrated health-monitoring sensors

Comparator

Professionally fitted prescription hearing aids