What a New OTC Hearing-Aid Study Can Teach Product Teams About Evidence
A new study of over-the-counter (OTC) hearing aids offers product teams a timely case study in how to read performance evidence carefully. Published online on October 13, 2026, the prospective cohort study evaluated 30 older adults with mild-to-moderate hearing loss using six hearing-aid models: one prescription model and five OTC models.
The authors assessed sound-field audiometry, word-recognition scores, speech perception in noise, and real-ear measurements. They reported variation in sound-field results across models, no statistically significant differences in word recognition or speech-in-noise outcomes, and appropriate real-ear fitting for the devices studied. The authors concluded that the OTC devices demonstrated performance comparable to the prescription device in this study population.
Start with the study question and population
Before applying a result to product planning or partner education, identify who was studied, which devices were included, and under what conditions. This study involved 30 older adults and six specific models. It is useful evidence about those participants, devices, measurements, and study procedures—not a universal ranking of OTC hearing aids or a prediction for every user.
Market category also matters. In the United States, OTC hearing aids are intended for adults 18 and older who perceive mild-to-moderate hearing loss. Regulatory categories and intended-use requirements differ by market, so a U.S. study should not be treated as global authorization or proof of suitability for other populations.
Read each outcome on its own terms
Audibility is not the same as speech understanding
Sound-field audiometry, word recognition, and speech-in-noise testing address different listening questions. A change in one measure does not automatically predict an equal change in another. The study's reported variation in sound-field audiometry alongside non-significant differences in word recognition and speech-in-noise outcomes is a reason to examine the endpoint-level results rather than collapse them into a single “better” or “worse” label.
Real-ear measures add fitting context
The researchers also used real-ear measurements (REMs), which assess sound delivered in the ear canal. Their abstract reports appropriate fitting for all devices in the study. That finding describes the study's fitting conditions; it does not establish that every OTC device will fit every ear, or that a result transfers to products not included in the comparison.
What the study does—and does not—establish
The findings contribute to a growing evidence base on OTC devices for older adults with mild-to-moderate hearing loss. But a 30-person cohort comparing a defined set of six models cannot settle all questions about long-term use, comfort, handling, connectivity, support, performance across different hearing profiles, or outcomes in everyday environments.
“Comparable” should therefore remain tied to the study's own population, comparator, endpoints, and conditions. It should not be rewritten as “all OTC hearing aids work as well as prescription hearing aids,” and it says nothing about Tomore devices, which were not part of the study.
A practical evidence review for product teams
- Confirm the intended user group and market before applying a finding.
- Review the sample, device models, fitting process, comparator, test environment, and follow-up period.
- Keep audibility, speech understanding, speech-in-noise performance, and real-ear results distinct.
- Check whether the evidence supports the exact wording, population, and conditions in a proposed claim.
- Separate peer-reviewed findings from manufacturer-provided product statements.
For brands and distributors, disciplined evidence review supports clearer conversations with customers and partners. A measured study can inform better questions and future validation work without serving as a substitute for model-specific evidence.
Tomore works with hearing-aid brands on digital products and OEM/ODM planning. Contact Tomore to discuss your target market, product requirements, and validation needs.