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，改善农村获得儿科医疗保健的机会

• 批准号: 10710056
• 负责人: Judson Heugel
• 金额: $ 85.98万
• 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/10710056
• 关键词: Acoustics; Acute; Affect; Age; Agreement; Algorithms; Calibration; Caregivers; Caring; Cellular Phone; Child; Child health care; Childhood; Classification; Clinic; Clinic Visits; Clinical; Clinical Research; Communities; Computerized Medical Record; Data; Detection; Devices; Diagnosis; Diagnostic; Digital Signal Processing; Ear; Education; External auditory canal; Face; Fees; Goals; Grant; Hand; Health Insurance Portability and Accountability Act; Health Services; 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; Qualifying; 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; Tympanic membrane; Tympanometry; Underserved Population; Visit; accurate diagnosis; aged; application programming interface; 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; smartphone based device; 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.

项目概要 急性中耳炎 (AOM) 是每年儿科就诊的主要原因，影响 85% 的 10 岁以下儿童 3 岁。每年有 1800 万人次因疑似 AOM 就医，这在今天是一项挑战 进行远程医疗，因为传统上诊断需要亲自进行体检。 对于无法轻易获得医疗服务的农村儿童来说尤其成问题，导致可能 治疗不足引起的并发症（听力损失、言语延迟、鼓膜穿孔）。 服务缺乏成功进行中耳液体检查的技术，这是体检的主要发现 Wavely Diagnostics 正在为非专业用户开发一种基于智能手机的工具，可准确检测。 我们的技术使用声反射测量法——一种基于阻抗的方法。 声音反射耳膜上的鸣叫声的技术 - 与机器学习算法配对以确定 在这个直接进入第二阶段 SBIR 项目中，具体目标是： 1) 开发一个现场测试。 校准过程以驱动智能手机之间的兼容性，2) 临床证明中耳的准确性 使用设备进行液体检测并与医生评估进行比较，3) 开发符合 HIPAA 标准的 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 中耳液体扫描仪用于在远程医疗环境中诊断 AOM 的实用程序。 该提案的成果是用于 AOM 检测的中耳流体扫描仪，该扫描仪将准备好广泛使用 鉴于智能手机在所有社区的普及，远程医疗服务为农村人口提供支持。 最近，远程医疗的使用有所增加，特别是在农村社区，这些社区正在对远程医疗进行大量投资。 宽带服务，以及对准确远程诊断的迫切需求，我们提出的系统具有 显着改善农村社区 1,340 万儿童的医疗保健机会。