Improving Rural Access to Pediatric Healthcare with Accurate Telehealth Diagnosis of Acute Otitis Media using Smartphone Acoustic Reflectometry

使用智能手机声反射测量法对急性中耳炎进行准确的远程医疗诊断，改善农村地区儿科医疗保健的可及性

• 批准号: 10600672
• 负责人: Judson Heugel
• 金额: $ 93.28万
• 依托单位: WAVELY DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-25 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10600672
• 关键词: Acoustics; Acute; Affect; Age; Agreement; Algorithms; Calibration; Caregivers; Caring; Cellular Phone; Child; Childhood; Clinic; Clinic Visits; Clinical; Clinical Research; Communities; Computerized Medical Record; Data; Detection; Devices; Diagnosis; Diagnostic; Digital Signal Processing; Ear; External auditory canal; Face; Fees; Goals; Grant; Hand; Health Insurance Portability and Accountability Act; Healthcare; Home; Image; Infrastructure; Investments; Legal patent; Letters; Modeling; Noise; Otitis Media; Otolaryngologist; Otoscopes; Outcome; Paper; Parents; Pathway interactions; Patients; Perforation; Persons; Phase; Physicians; Price; Process; Provider; Rural; Rural Community; Rural Population; Scanning; Sensitivity and Specificity; Services; Signal Transduction; Small Business Innovation Research Grant; Specificity; Speech Delay; System; Techniques; Technology; Telemedicine; Telephone; Testing; Time; Tympanic membrane; Underserved Population; Visit; accurate diagnosis; aged; application programming interface; base; commercial application; cost; cost effective; digital; ear infection; electric impedance; health care availability; hearing impairment; improved; interest; machine learning algorithm; microphone; middle ear fluid; smartphone Application; sound; telehealth; tool; virtual

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 (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.

项目摘要 急性中耳炎（AOM）是每年儿科就诊的主要原因，影响85%的儿童， 3岁。每年有1800万人因疑似AOM而就诊，今天， 由于诊断传统上需要亲自进行身体检查， 尤其是对于农村儿童来说，他们无法轻易获得医疗服务， 治疗不足引起的并发症（听力损失、言语延迟、鼓膜穿孔）。目前的远程保健 服务缺乏成功进行中耳液检查的技术，这是体检的关键发现 一个AOM。Wavely Diagnostics正在为普通用户开发一种基于智能手机的工具， 远程医疗访问期间中耳积液。我们的技术使用声反射测量-一种基于阻抗的 一种将声音从耳膜反射出来的技术，与机器学习算法相结合， 中耳液状态在这个直接到第二阶段SBIR项目中，具体目标是：1）开发一个现场 校准过程，以推动智能手机之间的兼容性，2）临床证明中耳的准确性 与医生评估相比，器械的液体检测，3）开发符合HIPAA的Wavely 应用程序编程接口（API）与远程医疗平台集成，以及4）验证临床 Wavely中耳流体扫描仪在远程医疗环境中诊断AOM的实用性。预期 这项建议的成果是一种用于AOM检测的中耳液扫描仪，它将准备好用于大规模使用 通过远程保健服务支持农村人口。鉴于智能手机在所有社区的普及， 最近远程保健的使用有所增加，特别是在农村社区， 宽带服务，以及对精确远程诊断的迫切需求，我们提出的系统具有 有可能显著改善农村社区1340万儿童的医疗保健服务。