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 (hearing loss, speech delay, eardrum perforation). Current telehealth services lack technology to successfully conduct a middle ear fluid exam, the 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 device as compared to physician assessment, 3) develop a HIPAA-compliant Wavely Application Programing Interface (API) to integrate with a telemedicine platform, and 4) validate the clinical utility of 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, 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.
Public Health Relevance Statement: PROJECT NARRATIVE Acute otitis media (AOM) is a leading cause of pediatric visits each year, yet pediatric visits can be 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. Wavely is developing a smartphone- based tool that enables timely and accurate diagnosis of ear infections over a virtual telehealth visit, increasing healthcare access for rural and underserved populations by expanding the capabilities of infrastructure (e.g. smartphones) already available in their communities.
Project Terms: Acoustics; Acoustic; Affect; Age; ages; Algorithms; Calibration; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Clinic Visits; Clinical Research; Clinical Study; Communities; Diagnosis; Digital Signal Processing; Ear; External auditory canal; Ear Canal; External Acoustic Meatus; Face; faces; facial; Fees; Goals; Grant; Hand; Investments; Persons; Noise; middle ear infection; Otitis Media; Paper; Parents; Patents; Legal patent; Patients; Physicians; Rural Population; Sensitivity and Specificity; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; sound; Specificity; Technology; Phone; Telephone; Testing; Time; Tympanic membrane; Eardrum; Membrana Tympanica; ear drum; Computerized Medical Record; Electronic Medical Record; Price; pricing; Caregivers; Care Givers; Healthcare; health care; Rural Community; Caring; electric impedance; Electrical Impedance; Impedance; Telemedicine; base; Otoscopes; improved; Acute; Clinical; Phase; pediatric; Childhood; Rural; Speech Delay; Otolaryngologist; Letters; tool; Diagnostic; Scanning; Clinic; Techniques; System; interest; Visit; Perforation; Services; HIPAA; Kennedy Kassebaum Act; PL 104-191; PL104-191; Public Law 104-191; United States Health Insurance Portability and Accountability Act; Health Insurance Portability and Accountability Act; Agreement; Devices; ear infection; Modeling; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; telehealth; Hearing Loss; Hypoacuses; Hypoacusis; dysfunctional hearing; hearing defect; hearing deficit; hearing difficulty; hearing disability; hearing dysfunction; hearing impairment; Data; Detection; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; Image; imaging; Pathway interactions; pathway; cost; virtual; digital; Underserved Population; under served group; under served people; under served population; underserved group; underserved people; Outcome; cost effective; aged; commercial application; accurate diagnosis; application programming interface; application program interface; health care availability; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; smartphone Application; Android App; Android Application; Cell Phone Application; Cell phone App; Cellular Phone App; Cellular Phone Application; Smart Phone App; Smart Phone Application; Smartphone App; iOS app; iOS application; iPhone App; iPhone Application; microphone; Infrastructure; machine learning algorithm; machine learned algorithm; machine learning based algorithm; middle ear fluid; fluid in the middle ear; Home
