Ear Canal Optical Coherence Tomography System

描述（由申请人提供）：国家耳聋和其他交流障碍研究所（NIDCD）支持创新技术的研究和开发，以提高助听器的质量和使用。物理光学公司（POC）提出了一种新的耳道光学相干断层扫描（ECOCT）系统的开发，该系统通过纯光学手段获得单个耳道的形状和相应的底层组织的三维图像，而不需要耳道印记。这种创新的系统将提高耳道形状测量的准确性（优于10¿m），并提供一个独特的机会，使用底层组织的3D地图来帮助消除助听器外壳对耳道中最敏感区域的过度压力。ECOCT系统获得的数字文件将通过互联网发送给助听器制造商，并且很容易存档或存储在个人记忆棒中。制造成本的节省将通过减少外壳返工来实现，以获得与耳道的完美配合。在第一阶段，POC通过组装一个概念验证原型，并通过幻耳模型展示其性能，证明了ECOCT概念的可行性。ECOCT系统测量三维形状和获得底层组织映射的能力为第二阶段原型的开发提供了坚实的基础。第一阶段的技术示范表明，在第二阶段成功开发商业上可行的系统是可行的。在第二阶段，POC将开发一个完全可操作的设备，用于耳道形状的数字测绘。该原型将在POC的耳朵模型上进行测试，然后在加州洛杉矶的House研究所进行人体实验。ECOCT二期原型的性能将与传统耳道印模技术进行对比评估。将开发软件，将ECOCT数据转换为标准格式，用于定制助听器制造。ECOCT系统的商业可行性将在第二阶段进行评估，并将与潜在的合作伙伴一起开始该系统的商业化工作。完全开发的ECOCT将为定制助听器设备的制造提供一种新的快速和更精确的测量耳道形状的方法。ECOCT技术还将用于制造各种专业人员（重型机械操作员，音乐家，机场人员，军队等）的个人噪声保护装置。制造个别安装的听力保护装置，有助员工接受，同时降低成本，并鼓励雇主强制雇员使用。因此，美国工人中听力损失的影响将会减少，这将对他们的生活质量产生重大影响。

DESCRIPTION (provided by applicant): The National Institute on Deafness and Other Communication Disorders (NIDCD) supports research and development of innovative technologies for improving the quality and use of hearing aid devices. Physical Optics Corporation (POC) proposes the development of a new Ear Canal Optical Coherent Tomography (ECOCT) system to obtain the shape of the individual ear canal and the corresponding 3D image of the underlying tissue by a purely optical means, without taking an ear canal imprint. This innovative system will improve the accuracy of ear canal shape measurements (to better than 10 ¿m) and provide a unique opportunity to use a 3D map of the underlying tissue to help eliminate excess pressure from the hearing aid shell impinging on the most sensitive areas in the ear canal. The digital file obtained by the ECOCT system will be sent to the hearing aid manufacturer through the Internet, and will be easily archived or stored on a personal memory stick. Manufacturing cost savings will be achieved through reduction of the shell rework to obtain a perfect fit into the ear canal. In Phase I, POC demonstrated the feasibility of the ECOCT concept by assembling a proof-of-concept prototype and demonstrating its performance with phantom ear models. The capabilities of the ECOCT system to measure the three-dimensional shapes and obtain mapping of the underlying tissue provides a strong foundation for the development of the Phase II prototype. The demonstration of the technologies in the course of Phase I show the feasibility of the successful development of a commercially viable system in the course of Phase II. In Phase II, POC will develop a fully operational device for digital mapping of the ear canal shape. The prototype will be tested with ear models at POC and then the operation of the prototype will be demonstrated with human subjects at the House Research Institute, Los Angeles, California. The performance of the ECOCT Phase II prototype will be evaluated against conventional ear canal impression techniques. Software will be developed for conversion of the ECOCT data into standard formats for custom hearing device manufacturing. The commercial viability of the ECOCT system will be evaluated in the course of Phase II and work will be initiated with potential partners for commercialization of the system. The fully developed ECOCT will provide a new rapid and more precise way of measuring ear canal shapes for custom fabrication of hearing aid devices. ECOCT technology will also be used for fabrication of individual noise protection devices for a wide variety of professionals (operators of heavy machinery, musicians, airport personnel, the military, etc.). Making individually fitted hearing protection devices will facilitate their acceptance by personnel while reducing cost, and will encourage employers to enforce their use by employees. As a result, less hearing loss effects will occur among American workers, which will have a significant impact on their quality of life.