Low-Cost User-Friendly Otoacoustic Emissions Probe

 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损害。其中，不到20%的人因各种原因寻求帮助。为了解决这个问题，国家耳聋和其他沟通障碍研究所（NIDCD）正在寻求解决方案，以改善听力保健的可及性并降低其成本。解决方案包括使目前可用的商品（电话，互联网和智能手机）能够进行听力损失的监测，互联网筛查系统和DPOAE筛查能够在传统的临床环境之外使用。 Creare建议完成听力筛查设备的开发，该设备测量耳声发射，并通过移动的平台进行控制。我们的设备设计用于人员和资源有限的偏远和非传统地区，以及发展中国家的广泛婴儿筛查。得益于我们的噪声抑制算法以及能够在探头上使用衰减耳罩以进一步降低外部噪声的设计，即使在噪声环境中也可以成功获得OAE测量。该设备是为低成本制造而设计的，并导致筛选系统的成本竞争力，甚至与学校中使用的最低成本的听力筛选器。由此产生的设备将为无法提供行为反应的人群提供听力保健服务问题的解决方案，允许在公共卫生计划和人道主义工作中进行大规模筛查，以及在资源最少的偏远地区。此外，由于其设计用于移动的平台，并根据适用的标准进行校准，因此拟议的设备将增强用于智能手机、平板电脑和互联网的高质量听力学应用程序的开发。 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方案测试其性能来证明我们创新的可行性。我们表明，DPOAEs测量与我们的原型是等效的DPOAEs测量与商业设备的试点人体研究，包括20名受试者。在第二阶段，我们将完善我们的设备的设计，建立几个集成的原型，并证明他们的使用和性能与几个人类受试者研究的目标位置和人群。II期人体研究有两个目的：（1）比较使用新器械与现有市售器械的测试结果和测试/复检变异性，以及（2）评价我们的器械在目标人群中的性能，以证明其能够增加服务不足人群的听力健康。 Creare团队非常有资格成功开发和商业化这种低成本的听力筛查设备，用于自动化和远程应用。我们的系统是通过利用Creare先前开发的用于各种环境中听力评估的硬件和软件而实现的，包括发展中国家的远程评估，嘈杂环境中的耳声发射（OAE）测量和高级听力保护。

 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.