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mHealth Tympanometer: A Digital Innovation to Address Preventable Childhood Hearing Loss in Low- and Middle-Income Countries

Award Number: R33DC020134
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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mHealth Tympanometer: A Digital Innovation to Address Preventable Childhood Hearing Loss in Low- and Middle-Income Countries - ABSTRACT Hearing loss is the second leading impairment worldwide. Childhood hearing loss has lifelong implications and disproportionately affects individuals in low- and middle-income countries (LMICs). Up to 75% of childhood hearing loss in LMICs is preventable due to the high prevalence of infection-related hearing loss. School hearing screening is critical for identification of childhood hearing loss in low resource settings, where newborn screening is unavailable. However, most screening programs only use pure-tone screening that does not identify middle ear disease widespread in populations with a high prevalence of infection-related hearing loss. This is because tympanometry, used to clinically identify middle ear disease, is expensive and designed for trained professionals. Our goal is to develop and validate an mHealth tympanometer with machine learning diagnostic support to transform this technology into a low-cost tool that could be broadly disseminated in LMICs, where the burden of hearing loss is greatest and is not addressed by current hearing screening methodology. Our study team is comprised of international leaders in hearing loss, audiology, data science, engineering, user- centered design, and device development in LMICs. We have also partnered with hearX, a University of Pretoria spinout company that developed the only validated mHealth pure-tone screening device. To test this new device in an appropriate LMIC setting, we have partnered with the South African site from the Global HEAR Collaborative, our consortium of collaborators from 28 countries that is the only international research network dedicated to hearing loss. We documented the need for this device in a large cluster randomized trial recently completed in rural Alaska, where tympanometry significantly improved the accuracy of school hearing screening in a population with a high prevalence of infection-related hearing loss. Using data from this trial and pilot funding, we are developing a machine learning tympanometry algorithm for lay screeners, and early hardware prototype fabrication is underway. In Aim 1, we will refine the hardware prototype using a user-centered design approach, cyclically incorporating feedback from South African team members during testing in a lab environment. In Aim 2, we will develop software through user-centered design that integrates the machine learning algorithm and refined hardware prototype. The resulting mHealth tympanometer will advance to the R33 phase. Technology development will be completed in Aims 3 and 4 through integration of the mHealth tympanometer with existing health information technology and an early feasibility study in 15 preschool children in South Africa to optimize device design for lay users. In Aim 5, we will validate the mHealth tympanometer with lay screeners through a clinical performance study in 500 preschool children in South Africa. This technology, developed through partnership and testing in an LMIC setting, will empower teachers and community health workers to identify children at risk for preventable hearing loss. The Global HEAR Collaborative will provide infrastructure for future studies with the proposed device across LMICs, directly addressing disparities in childhood hearing loss globally.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $293,466 )
2025	2025	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	001	6	9/4/2025	SUPPLEMENT FOR EXPANSION	$21,088
2025	2025	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	000	6	8/22/2025	NON-COMPETING CONTINUATION	$272,378
														Subtotal = $293,466

Issue Date FY: 2024 ( Subtotal = $370,435 )
2024	2024	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	001	5	7/12/2024	NON-COMPETING CONTINUATION	$291,316
2024	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	000	4	12/12/2023	EXTENSION WITH OR WITHOUT FUNDS	$79,119
														Subtotal = $370,435

Issue Date FY: 2023 ( Subtotal = $272,365 )
2023	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	001	4	8/25/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2023	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Research Related to Deafness and Communication Disorders	000	4	7/27/2023	EXTENSION WITH OR WITHOUT FUNDS	$272,365
														Subtotal = $272,365

Grand Total All Awards = $936,266

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mHealth Tympanometer: A Digital Innovation to Address Preventable Childhood Hearing Loss in Low- and Middle-Income Countries

Award Number: R33DC020134

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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