A Novel Ear Camera for Making Custom-Fit Hearing Devices

描述（由申请人提供）：根据国家耳聋和交流障碍研究所（NIDCD）的统计数据，超过2800万美国人患有某种类型的听力障碍。据估计，全世界有超过2.6亿人有听力障碍。由于涉及的人口众多，听力障碍是当今世界上排名第一的残疾。幸运的是，这些人中的许多人可以从使用助听器中受益。然而，助听器并不适合所有人。那些需要帮助的人需要仔细安装，以获得增强的听力功能。目前助听器定制外壳的制造过程是高度劳动密集型的手工过程，助听器的装配/性能的质量控制困难。定制装配过程从在听力学家或配药师的办公室对患者进行耳印开始。美国有8000个助听器分配器的吞吐量，许多人可以收费做耳印。然后将印模运送到制造商的实验室。每个外壳必须由熟练的技术人员使用手工操作定制。装配的质量和一致性因技师的技能水平而有很大差异。制作一个贝壳的典型过程从开始到结束大约需要40分钟。手工工艺的主要缺点包括：速度：手工和冗长的制造过程，不适合批量生产；延迟：物理印版从分配器到制造商的邮寄需要几天的时间。质量：质量缺乏一致性，导致产品返工和退货率高（目前典型退货率非常高（25%））；技术工人短缺，培训时间长。Genex Technologies, Inc （Genex）在此提出了一项SBIR项目，旨在开发一种新颖的三维（3D）耳相机技术，该技术有望消除传统的物理耳印，从而彻底改变当前定制助听器的制造工艺，并将听力学家带入“数字听力学”的新时代。这项SBIR工作的技术目标是研究一种微型、非接触式、低成本的手持式3D相机的可行性，该相机使听力学家能够获得外耳（耳廓）和时代管的多个3D图像，并产生完整的3D数字耳模型，作为“数字耳印”。然后，数字耳印数据通过互联网立即发送到制造商的实验室，大大缩短了交货时间。数字印象使助听器制造商能够利用计算机辅助设计（CAD）和计算机辅助制造（CAM）技术的最新突破，在一天的时间内生产大规模定制助听器。即使包括质量保险、电子校准和运送助听器，定制助听器的整个过程也将从几周缩短到几天。更重要的是，本文所要开发的数字印象技术将会提高配合的质量，从而增强残障人士的听力功能。

DESCRIPTION (provided by applicant): More than 28 million Americans suffer from some type of hearing impairment, according to the statistics from National Institute on Deafness and Communication Disorders (NIDCD). It is estimated that over 260 million people are hearing impaired worldwide. Based upon the huge population involved, the hearing impairment is the number one disability in today's world. Fortunately, many of these people can benefit from the use of hearing aid devices. However, hearing aids cannot work for everyone. Those who can be helped need to be carefully fitted in order to gain the enhanced hearing functionality. Current manufacturing process of custom-fit shells of hearing aids is highly labor-intensive and manual process and quality control of the fitting/performance of hearing aids is difficult. The custom-fitting process starts with taking ear impression of a patient at the office of an audiologist or dispenser. There are 8000 hearing aid dispensers' throughput the United States, many can make a ear impression for a fee. The impression is then shipped to manufacturer's laboratory. Each shell has to be custom-made by skilled technicians using manual operations. The quality and consistency of the fitting vary significantly with technician's skill level. A typical process of producing a shell takes about 40 minutes from start to finish. Major drawbacks of manual process include: Speed: manual and lengthy fabrication process and not scalable for mass production; Delay: The mailing of physical impressions from dispensers to manufacturers takes several days to deliver. Quality: lack of consistency of quality, resulting in high level of re-make and return of products (currently the typical return rate is very high (25%)); and shortage of skilled worker and long training time. Genex Technologies, Inc (GENEX) proposes herein a SBIR project to develop a novel Three Dimensional (3D) Ear Camera technology that promises to eliminate traditional physical ear impressions, thus revolutionizes current custom-fit hearing aid fabrication process and brings audiologists into a new era of "digital audiology". The technical objective of this SBIR effort is to investigate the feasibility of a miniature, non-contact, lowcost, handheld 3D camera that enables audiologists to acquire multiple 3D images of external ear (auricle) and era canal, and to produce complete 3D digital ear model that serves as a "digital ear impression". The digital ear impression data is then sent instantly to manufacture's lab via Intemet, reducing dramatically the delivery time. The digital impressions enable the hearing aid manufacturers to take advantages of the latest breakthrough of computer-aided-design (CAD) and computer aided manufacturing (CAM) technologies and product mass customization hearing aid device within one-day time frame. Even including the quality insurance, electronics calibration, and shipping back the hearing-aid device, the entire process making custom-fit hearing aid devices would be shorted from weeks to few days. More importantly, the digital impression technology to be developed herein would improve the quality of fit, thus enhance the hearing functionality for impaired people.