1 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Classification Agreement Between Prototype mHealth Tympanometer and Commercial TympanometerPrimary· Same day as participant visit, up to 10 minutes
Audiologist will test each ear of the participant first with the prototype device, interpret the results into one of the three tympanogram categories (Type A/B/C) and record the results. The procedure will be repeated with a commercial device. Agreement between the two devices with respect to the classification categories will be assessed.
Group
Value
95% CI
Tympanometer Comparison
93.33
Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth TympanometerPrimary· Same day as participant visit, up to 10 minutes
Tympanogram results collected using the prototype mHealth tympanometer will be run through the ML algorithm for classification into Type A/B/C. Agreement between the audiologist and the ML algorithm with respect to the classification categories will be assessed.
Group
Value
95% CI
Tympanometer Comparison
0.81
0.64 – 0.94
Sponsor's own description
Children in rural and underserved communities experience a disproportionately high burden of infection-related hearing loss, which is often preventable with timely identification and follow-up care. A tympanometer is a device that evaluates the health of the middle ear but is often not used in screening programs due to barriers of high cost and need for trained professionals such as audiologists to use the device. To address these barriers, a low cost, lay friendly, mobile health (mHealth) prototype tympanometer has been developed. In addition, a machine learning (ML) algorithm has been designed to guide lay users to interpret tympanometer results, overcoming the need for audiologists. Broad implementation of the lay friendly tympanometer and ML algorithm will transform screening in areas where prevalence of infection-related hearing loss is high, and access to specialty care is limited.
In this study the prototype mHealth tympanometer will be evaluated against commercial tympanometry. It will be used by audiologists, an essential step before testing the performance of the device with lay users. Approximately 20 adult patients and 10 pediatric patients with various middle ear pathologies will be enrolled in the study, with the goal of obtaining 60 ears with data from both the prototype and commercial tympanometers. Audiologists will obtain tympanometry measurements on both ears of each participant and interpret the results, first with the prototype device and then with the commercial tympanometer that is typically used during a clinical evaluation. Tympanometry interpretation will include classification into one of 3 categories (Type A, B, or C). Agreement in results between the prototype and commercial devices will be assessed. Agreement between audiologist interpretations and the ML algorithm from the prototype mHealth tympanometer will be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
Last refreshed: 13 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05666505.