Evaluation of a New mHealth Tympanometer

NCT ID: NCT05666505

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-30
• Study Completion Date: 2024-12-10

Brief Summary

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Tympanometer Comparison

Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer

Group Type: EXPERIMENTAL

Prototype mHealth tympanometer

Intervention Type: 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.

Standard of care commercial tympanometer

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Presenting to Audiology Clinic for evaluation, where tympanometry is warranted for testing at the discretion of the audiologist
• Presence of various middle ear health states/pathologies that result in Type A, B, C tympanograms
• English-speaking

Exclusion Criteria

• Children or adults with cognitive disabilities
• Unable to provide consent/assent
• Individuals who are unable to sit still
• Any other condition that in the opinion of the investigator, might interfere with the safe conduct of the study or place the participant at increased risk

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

274552

Identifier Type: -

Identifier Source: org_study_id