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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanometer Comparison | Experimental | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype mHealth tympanometer | Device | The prototype mHealth tympanometer functions similarly to a commercial tympanometer. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. |
| Measure | Description | Time Frame |
|---|---|---|
| Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer | 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. | Same day as participant visit, up to 10 minutes |
| Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth Tympanometer | 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. | Same day as participant visit, up to 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanometer Comparison | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanometer Comparison | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer | 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. | 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. | Posted | Number | Percent Agreement | Same day as participant visit, up to 10 minutes | Ears | Ears |
|
Adverse events were assessed twice on the day of the audiology clinic visit, once after testing with mHealth tympanometer, and once upon completion of the audiology clinic visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prototype mHealth Tympanometer | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer Prototype mHealth tympanometer: The prototype mHealth tympanometer functions similarly to a commercial tympanometer. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. Standard of care commercial tympanometer: A commercial tympanometer routinely used as part of standard of care will be used as the comparison. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samantha Kleindienst Robler, AuD, PhD | University of Arkansas for Medical Sciences | 9074340433 | skrobler@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2024 | Dec 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2024 | Dec 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Each participant will be first tested with prototype mHealth tympanometer, and then with a commercial tympanometer routinely used in clinical settings.
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| Standard of care commercial tympanometer | Device | A commercial tympanometer routinely used as part of standard of care will be used as the comparison. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. |
|
| Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Age, Categorical | Count of Participants | Participants |
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|
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| Primary | Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth Tympanometer | 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. | 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. | Posted | Number | 95% Confidence Interval | Kappa-statistic (Agreement) | Same day as participant visit, up to 10 minutes | Ears | Ears |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Standard of Care Commercial Tympanometer | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer Prototype mHealth tympanometer: The prototype mHealth tympanometer functions similarly to a commercial tympanometer. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. Standard of care commercial tympanometer: A commercial tympanometer routinely used as part of standard of care will be used as the comparison. Tympanometers are designed to assess middle ear function by measuring changes in acoustic tone related to subtle movement of the tympanic membrane from an applied air pressure sweep. An audiologist will review the tympanogram tracings and classify results as Type A, B, or C. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010031 | Otitis |