Evidence map›Paper›PMID 42592166›Full record

ReviewFrontiers in digital health2026

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

Naoya Itatani, Melissa Zavaglia

Abstract readReview
In one paragraph

Review in Frontiers in digital health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Naoya ItataniNeural Interfacing Group, Munich Institute of Robotics and Machine Intelligence, Technical University of Munich, Munich, Germany.
Melissa ZavagliaNeural Interfacing Group, Munich Institute of Robotics and Machine Intelligence, Technical University of Munich, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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, and the Cochrane Library and published between 2020 and 2026. In most randomized trials, self-fitted OTC hearing aids produced outcomes noninferior to professionally fitted devices, though one trial found audiologist-fitted hearing aids achieved better results. Consumer adoption has been incremental, with most OTC users still seeking professional support. Usability assessments found that many older adults had difficulty completing self-fitting tasks without error, and current self-fitting interfaces may not guide users toward optimal amplification. Accelerometry-based hearing aid sensors for gait analysis and energy expenditure demonstrated accuracy comparable to established reference and consumer devices. A prototype multi-sensor platform successfully measured temperature, oxygen saturation, heart rate, and respiration rate. Health sensors in hearing aids are technically validated but clinically unproven, as no study has linked sensor data to improved patient outcomes. If outcome studies confirm these uses, sensor-equipped hearing aids could become useful in geriatric medicine, cardiovascular monitoring, and fall prevention, linking audiology to wider medical care. Getting there will require prospective clinical trials, standard validation methods, and regulatory frameworks for dual-purpose devices.

Indexed as

gait analysishealth monitoringhearing aid fittingover-the-counter hearing aidswearable sensors

Identifiers

PMID42592166
PMCPMC13463186

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.