Wireless and Noise Attenuating Headset for Automated Hearing Screening

描述(申请人提供)：听力损失是一个主要的公共卫生问题，大约17%的美国成年人报告说有不同程度的损害。在这些人中，只有不到20%的人因为各种原因寻求帮助。为了解决这一问题，美国国家耳聋和其他沟通障碍研究所(NIDCD)正在寻找解决方案，以改善听力保健服务的获得并降低其成本(见RFA-DC-12-004)。要求的解决方案包括使目前可用的商品(电话、互联网和智能手机)能够进行听力损失监测、互联网筛查系统和自动测听，以便在传统的临床和研究环境之外使用。实施这些解决方案的一个关键挑战是需要生成校准音调并确保低噪声环境。 Creare建议完成一种听力阈值筛查设备的开发，该设备可以执行自动听力测试，并通过移动平台进行控制。我们的设备设计用于人员和测试设施非常有限的护理地点(POC) 资源；它也可用于自我评估。背景噪音衰减提供创新的、集成的高质量噪音衰减耳杯。通过允许在POC地点、社区中心、药店和大型商店(这些商店现在正在提供低成本助听器)进行高质量的筛查，所产生的设备将为听力健康保健提供解决方案。此外，由于该设备专为移动平台而设计，并根据适用的标准进行了校准，因此该设备将促进用于智能手机、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听力测试来测试其性能，从而证明了我们创新的可行性。我们发现，在一项包括16名受试者的试点人体研究中，用我们的原型测得的阈值与用商用听力计测得的阈值相当。在第二阶段，我们将改进我们的设备的设计，建立几个集成的原型，并通过几个目标地点和人群的人类主题研究来展示它们的用途和性能。第二阶段的人体研究将有两个目标：(1)比较使用新设备的测试结果和测试/重新测试的可变性，以及(2)比较我们的设备在典型噪声环境(如POC地点)中的性能与其在安静音响室中的性能。 Creare团队非常有资格成功地开发这种用于自动化和远程应用的听力筛查设备并将其商业化。我们的系统是通过利用Creare之前为各种环境下的听力评估而开发的硬件和软件实现的，这些环境包括发展中国家的远程评估、噪声环境中的耳声发射(OAE)测量以及高级听力保护。

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 (see RFA-DC-12-004). Solutions requested include enabling currently available commodities (telephone, Internet, and smartphones) to conduct surveillance of hearing loss, Internet screening systems, and automated audiometry to be used beyond traditional clinical and research environments. One key challenge to implementing these solutions is the need to generate calibrated tones and to ensure a low noise environment. Creare proposes to complete development of a hearing threshold screening device that performs automated audiometry and is controlled through a mobile platform. Our device is designed for use at point-of- care (POC) locations with very limited personnel and testing facility resources; it can also be used for self-assessment. Background noise attenuation is provided with innovative, integrated high quality noise attenuating ear cups. The resulting device will provide a solution to the problem of hearing healthcare access by allowing quality screening at POC locations, in community centers, pharmacies, and big box stores (which are now making low-cost hearing aids 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 audiometry. We showed that thresholds measured with our prototype were equivalent to thresholds measured with a commercial audiometer on a pilot human study that included 16 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 devices, and (2) compare the performance of our device in a representative noisy environment such as POC locations to its performance in a quiet sound booth. The Creare team is extremely well qualified to successfully develop and commercialize this 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.