Ear Canal Optical Coherent Tomography System

描述（由申请人提供）：

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.