Trial Outcomes & Findings for Evaluation of a New mHealth Tympanometer (NCT NCT05666505)

NCT ID: NCT05666505

Last Updated: 2026-01-13

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 39 participants
• Primary outcome timeframe: Same day as participant visit, up to 10 minutes
• Results posted on: 2026-01-13

Participant Flow

Participant milestones

Measure	Tympanometer Comparison Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer
Overall Study STARTED	39
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Tympanometer Comparison Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer
Overall Study Withdrawn due to caregiver consent obtained from non-legal guardian	1

Baseline Characteristics

Evaluation of a New mHealth Tympanometer

Baseline characteristics by cohort

Measure	Tympanometer Comparison n=38 Participants Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer
Sex: Female, Male Female	24 Participants n=210 Participants
Sex: Female, Male Male	14 Participants n=210 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants
Race (NIH/OMB) Asian	0 Participants n=210 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants
Race (NIH/OMB) Black or African American	7 Participants n=210 Participants
Race (NIH/OMB) White	26 Participants n=210 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=210 Participants
Age, Categorical <=18 years	16 Participants n=210 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=210 Participants
Age, Categorical >=65 years	11 Participants n=210 Participants

PRIMARY outcome

Timeframe: Same day as participant visit, up to 10 minutes

Population: The analytic sample is limited to ear-level results that produced a classification result of A/B/C for both devices. Ears were not included in the main analysis if data from one device or both devices were missing for that ear.

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.

Outcome measures

Measure	Tympanometer Comparison n=60 Ears Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer
Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer	93.33 Percent Agreement

PRIMARY outcome

Timeframe: Same day as participant visit, up to 10 minutes

Population: The analytic sample is limited to ear-level results that produced a classification result of A/B/C for both devices. Ears were not included in the main analysis if data from one device or both devices were missing for that ear.

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.

Outcome measures

Measure	Tympanometer Comparison n=60 Ears Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer
Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth Tympanometer	0.81 Kappa-statistic (Agreement) Interval 0.64 to 0.94

Adverse Events

Prototype mHealth Tympanometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Commercial Tympanometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samantha Kleindienst Robler, AuD, PhD

University of Arkansas for Medical Sciences

Phone: 9074340433

Email: skrobler@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place