Evaluation of a New mHealth Tympanometer
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
39 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal