Ear Canal Optical Coherent Tomography System

描述(由申请人提供)： 国家失聪和其他沟通障碍研究所(NIDCD)支持研究和开发创新技术，以提高助听器的质量和利用率。物理光学公司建议开发一种新的耳道光学相干层析成像(ECOCT)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，而不需要获取耳道印记。这一创新的系统将提高耳道形状测量的准确性(优于105米)，并提供独特的机会，使用底层组织的3D地图来帮助消除助听器外壳撞击到耳道最敏感区域的过量压力。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，并将很容易地存档或存储在个人记忆棒上。通过减少贝壳的返工以获得与耳道的完美匹配，将实现制造成本的节约。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、绘制组织图的能力等)。在第二阶段，POC将设计和制造一个完全可操作的原型，并在加利福尼亚州洛杉矶的House ear Institute的一个有代表性的患者池中测试其操作。 公共卫生相关性： 大约3600万美国成年人报告有不同程度的听力损失，并将从助听器的使用中受益。然而，出于对不便、不适、耻辱、化妆品、音质和负担能力的担忧，只有约20%的潜在助听器候选人实际使用了这些设备。设计个人助听器外壳的传统方法包括使用各种类型的印模材料获取耳道的印记，并将其发送到助听器制造商，在那里通过3-D激光扫描仪测量印记形状以用于随后的计算机辅助贝壳设计。制造印记的步骤是助听器制造中错误和需要返工的主要来源，导致助听器设备成本的显著增加和对声音质量的失望，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三维形状，具有更高的准确性，同时能够绘制下方组织的地图，以改善贝壳与耳道的适合性。在初级保健提供者办公室获得的耳道形状的数字文件和底层组织的地图将很容易地发送到贝壳制造商，并存档或存储在个人记忆棒上。ECOCT技术将降低助听器的成本(通过减少返工以获得更好的适合性)，并提高助听器的音质、使用的便利性和舒适性。

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.