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）支持研究和开发创新技术，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，以通过纯光学手段获得个体耳道的形状和下层组织的相应3D图像，而无需获取耳道印记。这一创新系统将提高耳道形状测量的准确性（优于10 μ m），并提供一个独特的机会，使用底层组织的3D地图，以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，并将轻松存档或存储在个人记忆棒上。通过减少壳体返工以获得与耳道的完美配合，将实现制造成本的节省。在第一阶段，POC通过组装概念验证原型并使用幻耳模型演示其性能，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II期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将开发一种完全可操作的设备，用于耳道形状的数字映射。原型将在POC用耳模型进行测试，然后在加州洛杉矶的众议院研究所用人类受试者演示原型的操作。ECOCT II期原型的性能将根据传统的耳道印模技术进行评价。将开发用于将ECOCT数据转换为定制听力设备制造标准格式的软件。将在第二阶段评估ECOCT系统的商业可行性，并将与潜在的合作伙伴一起启动该系统的商业化工作。完全开发的ECOCT将提供一种新的快速和更精确的测量耳道形状的方法，用于定制助听器设备。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、机场工作人员、军人等）的个人噪音保护装置。制作个性化的听力保护装置将有助于员工接受这些装置，同时降低成本，并鼓励雇主强制员工使用这些装置。因此，美国工人的听力损失影响将减少，这将对他们的生活质量产生重大影响。 大约有3600万美国成年人报告有一定程度的听力损失，并将从助听器的使用中受益。然而，只有约20%的潜在助听器候选人实际使用这些设备，因为不便，不适，耻辱，化妆品，音质和负担能力等问题。设计单个助听器外壳的传统方法涉及使用各种类型的印模材料获取耳道的印记，并将印记发送到助听器制造商，在那里通过3D激光扫描仪测量印记形状，用于随后的计算机辅助外壳设计。印记制作步骤是助听器制造中错误和返工的主要来源，导致助听器设备的成本显著增加，声音质量令人失望，以及患者的不适。耳道光学相干断层扫描（ECOCT）系统将通过纯光学手段提供单个耳道形状的数字3D成像，具有更高的准确性，同时能够映射底层组织，以改善外壳与耳道的配合。在初级保健提供者的办公室获得的耳道形状的数字文件和底层组织的地图将容易地发送到外壳制造商，并存档或存储在个人记忆棒上。ECOCT技术将降低助听器成本（通过减少返工以获得更好的适配），并提高助听器使用的音质、便利性和舒适度。

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. PUBLIC HEALTH RELEVANCE: Approximately 36 million American adults report some degree of hearing loss and would benefit from hearing aid use. However, only ~20% of potential hearing aid candidates actually use these devices because of issues such as inconvenience, discomfort, stigma, cosmetics, sound quality, and affordability. The conventional method of designing individual hearing aid shells involves taking imprints of the ear canal using various types of impression materials, and sending the imprints to a hearing aid manufacturer, where the imprint shape is measured by a 3D laser scanner for subsequent computer-assisted shell design. The imprint-making step is the major source of mistakes and the need for rework in hearing aid manufacturing, causing significant cost increases for hearing aid devices and disappointment with the sound quality, as well as discomfort for patients. The Ear Canal Optical Coherent Tomography (ECOCT) system will provide digital 3D imaging of the shape of individual ear canals by a purely optical means, with better accuracy, while enabling mapping of the underlying tissue to improve shell fit into the ear canal. The digital file of the ear canal shpe and the map of the underlying tissue obtained at the primary care provider's office will be easily sent to the shell manufacturer, and archived or stored on a personal memory stick. The ECOCT technology will reduce the hearing aid cost (by decreasing the rework to get a better fit) and improve the sound quality, convenience, and comfort of hearing aid use.