R33DC020134

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.

University Of Arkansas For Medical Sciences

TO INVESTIGATE SOLUTIONS TO PROBLEMS DIRECTLY RELEVANT TO INDIVIDUALS WITH DEAFNESS OR DISORDERS OF HUMAN COMMUNICATION IN THE AREAS OF HEARING, BALANCE, SMELL, TASTE, VOICE, SPEECH, AND LANGUAGE. THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS (NIDCD) SUPPORTS RESEARCH AND RESEARCH TRAINING, INCLUDING INVESTIGATION INTO THE ETIOLOGY, PATHOLOGY, DETECTION, TREATMENT, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES, PRIMARILY THROUGH THE SUPPORT OF BASIC AND APPLIED RESEARCH IN ANATOMY, AUDIOLOGY, BIOCHEMISTRY, BIOENGINEERING, EPIDEMIOLOGY, GENETICS, IMMUNOLOGY, MICROBIOLOGY, MOLECULAR BIOLOGY, THE NEUROSCIENCES, OTOLARYNGOLOGY, PSYCHOLOGY, PHARMACOLOGY, PHYSIOLOGY, PSYCHOPHYSICS, SPEECH-LANGUAGE PATHOLOGY, AND OTHER SCIENTIFIC DISCIPLINES. THE NIDCD SUPPORTS: (1) RESEARCH INTO THE EVALUATION OF TECHNIQUES AND DEVICES USED IN DIAGNOSIS, TREATMENT, REHABILITATION, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES, (2) RESEARCH INTO PREVENTION AND EARLY DETECTION AND DIAGNOSIS OF HEARING LOSS AND SPEECH, VOICE, AND LANGUAGE DISORDERS AND RESEARCH INTO PREVENTING THE EFFECTS OF SUCH DISORDERS BY MEANS OF APPROPRIATE REFERRAL AND REHABILITATION, (3) RESEARCH INTO THE DETECTION, TREATMENT, AND PREVENTION OF DISORDERS OF HEARING AND OTHER COMMUNICATION PROCESSES IN THE ELDERLY POPULATION AND ITS REHABILITATION TO ENSURE CONTINUED EFFECTIVE COMMUNICATION SKILLS, AND (4) RESEARCH TO EXPAND KNOWLEDGE OF THE EFFECTS OF ENVIRONMENTAL AGENTS THAT INFLUENCE HEARING OR OTHER COMMUNICATION PROCESSES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO ENCOURAGE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.173 - Research Related to Deafness and Communication Disorders

National Institute on Deafness and Other Communication Disorders (NIDCD) [HHS - NIH]

Little Rock, Arkansas 722057101 United States

Single Zip Code

Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21/R33 - Clinical Trial Optional) (PAR-19-376)

Amendment Since initial award the total obligations have increased 244% from $272,365 to $936,266.