RP303 - Interdisciplinary Team Science: Evolution of a Low-Cost Prototype Smartphone Tympanometer

Abstract:
Nearly 75% of childhood hearing loss is preventable in underserved regions of the world due to the high prevalence of ear infections. Yet screening programs do not often include tympanometry, a measure of middle ear health, because they are expensive tools designed for use by trained professionals. We established a collaboration of clinicians, researchers, and engineers to build a low-cost smartphone tympanometer. This presentation will describe how we are using team science to develop a low-cost smartphone tympanometer as part of the larger goal of reaching hearing health equity globally. Development and initial findings will be reviewed.

Rationale:
By 2050, one in four people will be affected by hearing loss in their lifetime. For children, hearing loss has lifelong implications, from academic outcomes to vocational opportunities. The majority of childhood hearing loss is preventable, with nearly 75% of hearing loss in low-resource settings due to the high prevalence of ear infections. Yet screening programs often do not include tympanometry, a measure of middle ear health, because they are expensive and designed for use by trained professionals. Schools are a critical access point for hearing care in remote settings, and prior work in rural Alaska has shown that tympanometry improves the accuracy of screening outcomes. However, cost and training for current commercial tympanometers are barriers to uptake in screening programs.
Low-cost commercial tympanometers do not exist to date due to the complexity of technology, the balance of building a precision instrument with a smaller budget, and the perceived lack of market demand for this type of low-cost device. We set out to overcome these challenges by bringing together a team of interdisciplinary experts including clinicians, engineers, researchers, and students. Here we present our team science approach to rapidly developing a low-cost, lay-friendly smartphone tympanometer and the initial results from a form factor evaluation with audiologists.

Design:
Our interdisciplinary team includes expertise in biomedical engineering, software development, machine learning, and clinical knowledge. Our team science approach includes real-time knowledge exchange, iterative development, and a student mentoring program. We also have established partnerships with practicing audiologists to obtain expert opinions on device feasibility in the form of focus groups, as well as conduct a first-in-human study, leading to a larger study to validate the prototype device.

Results:
Iterative team meetings and multiple rounds of form factor testing and analysis, alongside device performance testing and troubleshooting, have resulted in the rapid innovation of a low-cost smartphone tympanometer. Form factor evaluation of the device by clinical audiologists (n=15) resulted in feedback on design, comfort, ease of use, and overall user experience. Issues were ranked as ‘critical’, ‘early refinement’, ‘later refinement’, or ‘not-applicable’. The results of the thematic analysis were reviewed in close collaboration with the scientific team, and after a consensus was reached, refinements were addressed accordingly. Several themes emerged requiring critical refinement before first-in-human testing, including ear tip adjustments, handle modifications for stability, and timing of ambient pressure measurement and actuator reset.

Conclusions:
Collaborations among clinicians and researchers across disciplines and organizations is vital for addressing complex challenges. Tympanometry is an essential tool for screening programs in low-resource settings, but a low-cost, lay-friendly commercial tympanometer does not yet exist. We are using robust interdisciplinary team science to overcome the challenge of designing and building a precision tool, such as a tympanometer, to be accessible in low-resource settings. Findings from this study to date have resulted in a refined prototype well-positioned for the clinical validation study and ultimately for commercialization and dissemination to low-resource settings to directly address hearing loss disparities for those that need it most.