Low-Cost User-Friendly Otoacoustic Emissions Probe

低成本、用户友好的耳声发射探头

• 批准号: 9243238
• 负责人: ODILE H CLAVIER
• 金额: $ 70.71万
• 依托单位: CREARE, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-07 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9243238
• 关键词: Address; Adult; Adult Acute Lymphocytic Leukemia; Age; Algorithms; American; Attenuated; Audiology; Biological; Cellular Phone; Child; Clinic; Clinical; Clinical Protocols; Communication impairment; Communities; Computer software; Concha; Controlled Environment; Cost Savings; Country; Developing Countries; Development; Devices; Diagnostic; Ear; Earmuff; Electronics; Environment; Evaluation; External auditory canal; Family; Feedback; Funding; Government; Head; Health; Health Services; Healthcare; Hearing; Hearing problem; Home environment; Human Resources; Impairment; Improve Access; Individual; Infant; Intellectual functioning disability; International; Internet; Letters; Licensing; Location; Measurement; Measures; Medical Students; Methods; Migrant Workers; Monitor; Noise; Nomads; Nurses; Patients; Performance; Peripheral; Persons; Phase; Population; Protocols documentation; Public Health; Recruitment Activity; Reporting; Resources; Schools; Signal Transduction; Stimulus; Students; Study Subject; Surveys; System; Tablets; Target Populations; Technology; Telephone; Test Result; Testing; Time; Training; Underserved Population; Wireless Technology; Work; base; behavioral response; cohort; commercialization; computerized; cost; deafness; design; digital; farm worker; farmer; health care availability; hearing impairment; hearing screening; help-seeking behavior; human study; human subject; improved; innovation; innovative technologies; interest; mobile computing; monitoring device; otoacoustic emission; portability; programs; prototype; public health relevance; remote location; response; screening; telehealth; tool; usability; user-friendly

 DESCRIPTION (provided by applicant): Hearing loss is a leading public health concern, with about 17% of American adults reporting some degree of impairment. Of those, fewer than 20% seek help for their condition for a variety of reasons. To address this issue, the National Institue of Deafness and Other Communication Disorders (NIDCD) is seeking solutions to improve hearing healthcare access and lower its cost. Solutions include enabling currently available commodities (telephone, Internet, and smartphones) to conduct surveillance of hearing loss, Internet screening systems, and DPOAE screening to be used beyond traditional clinical environments. Creare proposes to complete development of a hearing screening device that measures Otoacoustic Emissions and is controlled through a mobile platform. Our device is designed for use in remote and non- traditional locations with limited personnel and resources as well as for widespread infant screening in the developing world. OAE measurements can be successfully obtained even in noise environments thanks to our noise rejection algorithms as well as a design that enables the use of attenuating earmuffs over the probe to further reduce external noise. The device is designed for low-cost manufacturing and results in a screening system that is cost competitive with even the lowest cost audiometric screeners used in schools. The resulting device will provide a solution to the problem of hearing healthcare access for populations who are unable to provide behavioral responses by allowing wide-scale screening in public health programs and humanitarian efforts, as well as in remote locations where minimal resources are available. In addition, because it is designed for use with mobile platforms and is calibrated to applicable standards, the proposed device will enhance the development of quality audiology applications for use with smartphones, tablets, and the Internet. During Phase I, we demonstrated the feasibility of our innovation by building a benchtop prototype of the device and testing its performance using standard clinical protocols. We showed that DPOAEs measured with our prototype were equivalent to DPOAEs measured with a commercial device on a pilot human study that included 20 subjects. During Phase II, we will refine the design of our device, build several integrated prototypes, and demonstrate their use and performance with several human subject studies in target locations and populations. The Phase II human study will have two objectives: (1) compare the test results and test/retest variability using the new device to what can be achieved with existing commercial devices, and (2) evaluate the performance of our device in the target populations to demonstrate its ability to increase access to hearing health in underserved populations. The Creare team is extremely well qualified to successfully develop and commercialize this low-cost hearing screening device for automated and remote applications. Our system is made possible by leveraging hardware and software that Creare has previously developed for hearing assessment in varied settings including remote assessment in developing countries, Otoacoustic Emission (OAE) measurement in noisy environments, and advanced hearing protection.

 描述（由申请人提供）：听力损失是一个主要的公共卫生问题，大约 17% 的美国成年人报告有一定程度的听力损失，其中只有不到 20% 的人因各种原因寻求帮助来解决这一问题。针对这一问题，国家耳聋和其他沟通障碍研究所 (NIDCD) 正在寻求解决方案，以改善听力保健服务的可及性并降低其成本。 Creare 提议完成听力筛查设备的开发，该设备可测量耳声发射并通过移动平台进行控制。 - 得益于我们的噪声抑制算法以及能够在耳罩上方使用衰减耳罩的设计，即使在人员和资源有限的传统地点以及发展中国家广泛的婴儿筛查中，即使在噪声环境中也可以成功获得 OAE 测量结果。探测该设备专为低成本制造而设计，其筛查系统即使与学校使用的成本最低的听力筛查仪相比也具有成本竞争力，最终的设备将为听力保健获取问题提供解决方案。适用于无法通过公共卫生计划和人道主义工作进行大规模筛查以及在可用资源最少的偏远地区提供行为反应的人群。此外，因为它是专为与移动平台一起使用而设计的，并且经过了校准。根据适用的标准，拟议的设备将提高质量的发展在第一阶段，我们通过构建设备的台式原型并使用标准临床协议测试其性能来证明我们的创新的可行性。相当于在包括 20 名受试者的试点人体研究中使用商业设备测量的 DPOAE。在第二阶段，我们将改进设备的设计，构建多个集成原型，并通过在目标位置进行的多个人体受试者研究来展示其用途和性能。和人口。 II 人体研究将有两个目标：(1) 将使用新设备的测试结果和测试/重新测试变异性与现有商业设备所能达到的结果进行比较，以及 (2) 评估我们的设备在目标人群中的性能，以证明Creare 团队非常有能力成功开发这种用于自动化和远程应用的低成本听力筛查设备并将其商业化，我们的系统是通过利用 Creare 拥有的硬件和软件实现的。以前开发用于各种环境下的听力评估，包括远程评估发展中国家、噪声环境中的耳声发射 (OAE) 测量以及先进的听力保护。