New Duke device could help tackle preventable hearing loss in children

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DURHAM- The World Health Organization (WHO) estimates that around 60% of hearing loss in children could be avoided through preventive measures. Preventable hearing loss in children also disproportionately affects underserved populations and has lifelong consequences on language development, academic achievement and future employment opportunities.

A first-generation prototype of the tympanometer that can modulate pressure, generate sound, and measure sound reflected from the tympanic membrane. (Photo via Duke University)

Samantha Robler, AuD, PhD, of Norton Sound Health Corporation and Susan D. Emmett, MD, MPH, associate professor of head and neck surgery and audiology and associate professor of global health at Duke University, made research on hearing loss in children in remote and rural Alaska. Their work identified a gap in screening tools that can be used to identify children with hearing loss.

Current tympanometers, used to identify middle ear diseases, such as ear infections, are available, but they are expensive and require trained audiologists, like Robler, to use and interpret the results. The inclusion of a tool to identify middle ear disease is important for screening programs in underserved populations, where the prevalence of infection-related hearing loss is often high. However, current screening programs generally do not include this tool due to cost and the need for an audiologist to perform the test.

Robler and Emmett saw the need for an affordable and accessible tympanometer that could be used in schools and by community health workers and clinicians, especially those in remote areas, to screen for hearing loss in children. “Tympanometry is an essential tool for assessing infection-related hearing loss, but a mobile, user-friendly tympanometer to support mass screening programs simply does not exist,” Robler said.

Robler and Emmett approached Mark Palmeri, MD, PhD, professor of practice in the department of biomedical engineering at Duke’s Pratt School of Engineering and director of the BME Design Fellows program, about the potential for developing an innovative solution to make tympanometry accessible , affordable and easy to use. A new collaboration has been formed bringing together clinicians, engineers, data scientists and Alaska-based Norton Sound Health Corporation to create a solution.

The team applied for funding from Duke MEDx (Medicine + Engineering) and received a grant in 2020 to start the project.

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“MEDx helped find a home for this project with seed funding. The project was truly a labor of love and thanks to the support of MEDx, we were able to launch this project,” said Palmeri.

Palmeri and his team, including Duke graduate students and undergraduate BME Design Fellows, have developed a new mobile health (mHealth) tympanometer with a machine learning interface. The team believe their mHealth tympanometer will have wide applicability and has the potential to improve diagnostics in community health settings, where access to a specialist may be limited. Teachers, school nurses, and frontline healthcare providers could use the mHealth Tympanometer for school and community screening to identify children in need of hearing and hearing care.

Machine learning is an integral part of this platform that allows a layman to acquire the data and then have the device interpret the data to guide clinical decisions. Funding from the Duke Global Health Institute enabled the development and evaluation of the utility of machine learning to automate an mHealth tympanometer. Felix Jin and Ouwen Huang, students in the Medical Scientists Training Program who are pursuing doctorates at Pratt, took charge of this part of the project with guidance from Palmeri and his team.

Palmeri’s engineering team has developed a hardware prototype that can be used with a smartphone. Duke engineering student teams demonstrated the “proof of concept” of the prototype, showing that it meets the requirements of low cost, ease of use, comfort when placed in the ear of a child – running fast enough to be an effective screening tool.

“This project has given me and my peers the opportunity to use our individual skills and see the project come to fruition,” said Duke biomedical engineering undergraduate student Alexander Chen. “I specifically discovered a passion for computer-aided electronic design after working with Dr. Palmeri and other students to find working components in the project to test and improve designs. The project is for a greater cause that gives us hands-on experience in supporting life-changing innovation.

Currently, the multidisciplinary team is working on the device’s subsystems to refine specifications and find creative ways to reduce costs. By the end of 2022, the team expects the device to be ready to be delivered for beta testing with volunteers. They aim to start getting the device into clinical trials in 2023.

“There is currently no tool available and competitive on the market like the tympanometer that we have developed,” Palmeri said. “COVID home testing has really accelerated the desire for these accessible and cost-effective tests. The long-term goal would be to implement this in our communities and clinically, and then be able to offer these screening tests as an option that parents and caregivers could buy and use at home.

The team believe that the mHealth tympanometer could benefit children around the world and ensure that they too are able to reach their full potential.

“Our innovative approach that combines low-cost mHealth technology with machine learning represents a major step forward in addressing childhood hearing loss in underserved populations globally,” Emmett added. “It’s exciting to see this new collaboration, supported by MEDx, making significant progress on such an important public health issue.”

Duke students involved in the project participate in Duke’s BME Design Fellows courses. Palmeri co-teach courses with Eric Richardson, PhD, associate professor in the practice of biomedical engineering and director of Duke Design Health, with support from BME laboratory staff director Matt Brown. The following Duke students have participated in the mHealth Tympanometer Project:

  • Robert Baldoni Jr. (2020)
  • Bradley Howard (2020)
  • Tika Gergaia (2021)
  • Manav Vakil (2021)
  • Alex Chen (2022)
  • Vanessa Tam (2022)
  • Jarrett Dobbins (2022)
  • Molly Chakraborty (2022)
  • Amanda Stull (2022)
  • Zach Thompson (2022)

(C) Duke University

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