Ear Canal Optical Coherent Tomography System

描述（由申请人提供）： 国家耳聋和其他沟通障碍研究所（NIDCD）支持创新技术的研究和开发，以提高助听器的质量和利用率。Physical Optics Corporation提出开发一种新的耳道光学相干断层扫描（ECOCT）系统，以通过纯光学手段获得个体耳道的形状和底层组织的相应3-D图像，而不需要进行耳道印记。这种创新的系统将提高耳道形状测量的准确性（优于10 5 m），并提供一个独特的机会，使用底层组织的3-D地图，以帮助消除来自助听器外壳的过多压力冲击耳道中最敏感的区域。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将设计、制造、组装和测试实验室原型，并展示其主要操作参数（测量精度、操作速度、映射底层组织的能力等）。在第二阶段，POC将设计和制造一个完全可操作的原型，并在加州洛杉矶的豪斯耳研究所的一组代表性患者身上测试其操作。 公共卫生相关性： 大约有3600万美国成年人报告了一定程度的听力损失，并将从助听器的使用中受益。然而，由于担心不便，不适，耻辱，化妆品，音质和负担能力，只有约20%的潜在助听器候选人实际使用这些设备。设计个体助听器外壳的常规方法涉及使用各种类型的印模材料获取耳道的印模，并将其发送到助听器制造商，在那里通过3-D激光扫描仪测量印模形状以用于随后的计算机辅助外壳设计。制作印记的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的数字3D形状，具有更高的准确性，同时能够映射底层组织，以改善耳道中的外壳配合。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 utilization of hearing aid devices. Physical Optics Corporation proposes development of a new Ear Canal Optical Coherent Tomography (ECOCT) system to obtain the shape of the individual ear canal and the corresponding 3-D 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 5m), and provide a unique opportunity of using a 3-D map of the underlying tissue to help eliminate the 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 re-work to obtain a perfect fit into the ear canal. In Phase I, POC will design, fabricate, assemble, and test the laboratory prototype, and demonstrate its major operational parameters (accuracy of measurements, speed of operation, capability of mapping underlying tissue, etc.) In Phase II, POC will design and fabricate a fully operational prototype and test its operation on a representative pool of patients at the House Ear Institute in Los Angeles, California. PUBLIC HEALTH RELEVANCE: Approximately 36 million American adults report some degree of hearing loss and would benefit from hearing aid use. However, only ~20 percent of potential hearing aid candidates actually use these devices, owing to concerns about inconvenience, discomfort, stigma, cosmetics, sound quality, and affordability. The conventional method of design of the individual hearing aid shell involves taking imprints of the ear canal using various types of impression materials, and sending it to a hearing aid manufacturer, where the imprint shape is measured by a 3-D laser scanner for subsequent computer assisted shell design. The step of making imprints 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 a digital 3-D 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 shape 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.