Hearing LossNCT05666505
Evaluation of a New mHealth Tympanometer
A study testing Prototype mHealth tympanometer in people with Hearing Loss, run by University of Arkansas.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Prototype mHealth tympanometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Pilot Study to Assess Performance of a New Low-Cost Mobile Health Based Prototype Tympanometer
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
- Being tested
- Prototype mHealth tympanometer, Standard of care commercial tympanometer
- Keywords
- Rural, Screening, Tympanometer, Mobile health (mHealth), Otitis media, ML Algorithm
- Medical subject headings
- Hearing Loss, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype mHealth tympanometerDevice
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 tympanometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tympanometer Comparison | Experimental | Both ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer Receives: Device: Prototype mHealth tympanometer; Device: Standard of care commercial tympanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Same day as participant visit, up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start30 Oct 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be first tested with prototype mHealth tympanometer, and then with a commercial tympanometer routinely used in clinical settings.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666505
- Sponsor's protocol ID
- 274552
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2022
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Performance of a New Low-Cost Mobile Health Based Prototype Tympanometer
- ClinicalTrials.gov ID
- NCT05666505
- Acronym / sponsor ID
- 274552
- Conditions
- Hearing Loss
- Keywords
- Rural, Screening, Tympanometer, Mobile health (mHealth), Otitis media, ML Algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be first tested with prototype mHealth tympanometer, and then with a commercial tympanometer routinely used in clinical settings.
| Arm | Type | Receives |
|---|---|---|
| Tympanometer Comparison | Experimental | Device: Prototype mHealth tympanometer, Device: Standard of care commercial tympanometerBoth ears of each participant will be tested first with the prototype mHealth tympanometer followed by standard of care commercial tympanometer |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype mHealth tympanometerThe 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. | Device | Tympanometer Comparison |
| Standard of care commercial tympanometerA 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. | Device | Tympanometer Comparison |
Primary outcome
Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer
Time frame: 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.
Classification Agreement Between Audiologist and ML Algorithm Interpretations Using Prototype mHealth Tympanometer
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype mHealth tympanometer in people with Hearing Loss, run by University of Arkansas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification Agreement Between Prototype mHealth Tympanometer and Commercial Tympanometer (time frame: Same day as participant visit, up to 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.