Improving Rural Access to Pediatric Health Care with Accurate Telehealth Diagnosis of Acute Otitis Media via Wide Scale Use of Smartphone Acoustic Reflectometry

PROJECT SUMMARY Acute otitis media (AOM) is a common condition, affecting 80% of children under the age of three. There are 30 million annual visits in the United States due to suspected AOM. While telehealth improves access to health care services, AOM visits are challenging because diagnosis traditionally requires in-person exams. This challenge is particularly acute for rural children, as studies have shown that disadvantaged children with limited access to health care services are less likely to receive treatment for AOM and are more likely to develop complications, such as hearing loss, speech delay, or eardrum perforation. Current telehealth services lack technology to successfully conduct a middle ear exam. Wavely Diagnostics (“WavelyDx”) has developed a smartphone-based tool for lay users that accurately detects middle ear fluid (the hallmark of AOM) during a telehealth visit. The technology uses acoustic reflectometry—an evidence-based technique that reflects sound waves off the eardrum—paired with advanced signal processing and machine learning algorithms to determine middle ear fluid. In WavelyDx’s Phase II SBIR project, the company developed the technology so it could be used widely. In this Phase IIb SBIR proposal the company will remove remaining barriers to deploying the technology at greater scale. The specific aims are: 1) develop a make-at-home waveguide to remove physical barriers to widespread on-demand use, 2) clinically demonstrate accuracy of middle ear fluid detection in real-world use, 3) demonstrate economic Return On Investment (ROI) for care delivery organizations and/or health plans using WavelyDx to increase the frequency and quality of telehealth use for children. The proposal aims to deliver a Middle Ear Fluid Scanner for virtual AOM management, enabling widescale adoption by telehealth providers, particularly in rural communities. With the ubiquity of smartphones, growing telehealth adoption (especially in rural communities benefiting from broadband expansion), and the need for accurate remote diagnostics, this system could transform access to health care for 13.4 million children in rural communities.