R44MD018225

Improving Rural Access to Pediatric Healthcare with Accurate Telehealth Diagnosis of Acute Otitis Media Using Smartphone Acoustic Reflectometry - Project Summary

Acute Otitis Media (AOM) is a leading cause of pediatric visits each year, affecting 85% of children under the age of 3. There are 18 million annual doctor visits due to suspected AOM, which today are challenging to conduct over telehealth because diagnosis traditionally requires an in-person physical exam. This is particularly problematic for rural children who can't easily access healthcare services, leading to possible complications from under-treatment such as hearing loss, speech delay, and eardrum perforation.

Current telehealth services lack the technology to successfully conduct a middle ear fluid exam, which is a key finding of the physical exam for an AOM. Wavely Diagnostics is developing a smartphone-based tool for lay users that accurately detects middle ear fluid during a telehealth visit. Our technology uses acoustic reflectometry—an impedance-based technique that reflects sound chirps off the eardrum—paired with machine learning algorithms to determine middle ear fluid status.

In this Direct to Phase II SBIR project, the specific aims are:

1) Develop an in-field calibration process to drive compatibility across smartphones.
2) Clinically demonstrate accuracy of middle ear fluid detection with the device as compared to physician assessment.
3) Develop a HIPAA-compliant Wavely Application Programming Interface (API) to integrate with a telemedicine platform.
4) Validate the clinical utility of the Wavely middle ear fluid scanner for diagnosing AOM in a telemedicine setting.

The expected outcome of this proposal is a middle ear fluid scanner for AOM detection that will be ready for widescale use by telehealth services supporting rural populations. Given the ubiquity of smartphones across all communities, the recent rise in telehealth usage, particularly in rural communities where significant investment is being made in broadband services, and the critical need for accurate remote diagnostics, our proposed system has the potential to significantly improve healthcare access for the 13.4 million children in rural communities.

Wavely Diagnostics

NOT APPLICABLE

93.307 - Minority Health and Health Disparities Research

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

Seattle, Washington 981036947 United States

Single Zip Code

PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-24-245)

Amendment Since initial award the End Date has been extended from 06/30/24 to 04/30/27 and the total obligations have increased 317% from $932,835 to $3,888,309.