Completely Digitizing the Custom-Fit Hearing Aid Shell Manufacturing Process

描述（由申请人提供）：助听器的平均价格为1,500美元，但价格可能高达5,000美元。然而，消费者报告显示，40%的助听器用户对他们的设备不满意。25%到30%的定制助听器被退回和/或需要重新制作，另外20%的助听器最终被闲置在抽屉里。同样令人不安的是，在世界上需要助听器的3亿人中，发达国家只有不到20%的人拥有助听器，其余国家只有不到1%的人拥有助听器。 这种困境的主要原因在于仍然涉及助听器外壳3D采集的手动过程的过时技术。事实上，制作每一种助听器通常都需要将硅基粘稠物喷入耳朵中，使其硬化，从而为助听器制作一个模具。然而，这一过程并不完美：在提取过程中，模具可能会使耳朵变形甚至损坏，如果得到的助听器不完全合适，可能会导致刺激，刮伤或感染。这也会降低佩戴者的声音质量。快速而有效地装配辅助工具一直是该行业的一个真实的瓶颈。开发一种易于使用且低成本的耳道直接3D扫描技术是数字助听器行业的“圣杯”，迫切需要提高外壳制造质量并彻底改变现状。 所提出的3DScope相机系统完全消除了手动获得助听器模具过程的需要。相反，它完全数字化了听力模型采集，数据建模和制造过程，成本更低，精度更高。3DScope设计带来了以下主要创新：“创新的直接耳内3D建模过程，完全消除了物理干扰;“创新的微型3D和3600成像光学器件，以前从未报道过;“独特的基于多传感器融合的硬件平台;和“创新的IMU增强3D运动形状（SFM）算法。 这项技术突破将使定制助听器的零售价格降低500至800美元，或每年高达40亿美元。联合收割机的价格更低，满意度更高，助听器的销售可能会从潜在用户的15%增加到30%，这是不合理的假设，这将大大扩大患者基础，使这项技术受益，每年增加近100亿美元，带来额外的就业机会和连锁经济效益。除了助听器行业，该系统还可以为下一代手机和“可穿戴”计算机创造最佳适配音频设备铺平道路。 公共卫生相关性：在这项SBIR计划下发展的三维数字采集系统和技术，将为听障患者提供更低成本和更高准确度的助听器设备，为他们带来巨大的利益。所提出的系统提供了一种创新的三维和全景成像技术，从而减少了患者的不适感，大大缩短了助听器的制造时间，但获得了更高的准确度。我们预计该设备将大大减少助听器行业臭名昭著的3R（退货/维修/重制）问题。这项技术突破可以将定制助听器的零售价格降低500至800美元，或每年高达40亿美元。联合收割机的价格更低，满意度更高，助听器的销售可能会从潜在用户的15%增加到30%，这是不合理的假设，这将大大扩大患者基础，使这项技术受益，每年增加近100亿美元，带来额外的就业机会和连锁经济效益。受益于这项技术的非医疗领域包括手机耳机和娱乐业--另一个数十亿美元的市场。

DESCRIPTION (provided by applicant): The average hearing aid costs $1,500, but prices can go up to $5,000 each. Yet Consumer Reports indicates that 40 percent of hearing aid users are unhappy with their devices. Between 25 percent and 30 percent of custom-fit hearing aids are returned and/or need to be remade and another 20 percent end up sitting unused in a bureau drawer. Just as disturbing, of the 300 million people in the world who need hearing aids, less than 20 percent of people in developed countries and less than 1 percent of the rest actually have hearing aids. The main reason for this dilemma lies in the dated technology that still involves manual process for 3D acquisition of hearing aid shell. In fact, creating each aid typically involves squirting into the ear silicon-based goop that hardens to create a mold for the aid. The process is however imperfect: molds can deform or even damage the ear during extraction, and if the resulting hearing aid does not fit perfectly, it can lead to irritation, scratching, or infection. This can also decrease the sound quality for the wearer. Fitting aids well and quickly has been a real bottleneck in the industry. Developing an easy to use and low cost direct 3D scanning of the ear canal technology is the "holy grail" of digital hearing aid industry and is urgently needed to improve shell manufacturing quality and revolutionize current situations. The proposed 3DScope camera system completely eliminates the need of the manually obtaining hearing aid mold process. Instead, it completely digitizes the hearing mold acquisition, data modeling, and fabrication process with much lower cost and higher accuracy. 3DScope design leads to the following major innovations: " Innovative Direct Intra-ear 3D Modeling Process that Totally Eliminates Physical Impressions; " Innovative Miniature 3D and 3600 Imaging Optics Never Reported Before; " A Unique Multi-Sensor Fusion Based Hardware Platform; and " Innovative IMU Augmented 3D Shape from Motion (SFM) Algorithms. The technological breakthrough will reduce retail prices for custom hearing aids by $500 to $800, or up to $4 billion annually. Combine lower prices with greater satisfaction, and it is not unreasonable to assume that the sale of hearing aids could double from 15 percent of potential users to 30 percent, a vast expansion of patient base to benefit this technology and an increase of almost $10 billion annually, bringing with it additional jobs and ripple-economic benefits. In addition to the hearing aid industry, the proposed system can also pave the way for the creation of optimally fitting audio devices for the next generation of cell phones and "wearable" computers potentially PUBLIC HEALTH RELEVANCE: The three-dimensional digital acquisition system and technology developed under this SBIR project will provide great benefit to hearing impaired patients by providing much lower cost and higher accuracy hearing aid device. The proposed system provides an innovative three- dimensional and panoramic imaging technique leading to less discomfort to patients, much shorter hearing aid fabrication time yet with much higher accurate results. We anticipate the device will significantly reduce the infamous 3R (return/repair/remake) problem in the hearing aid industry. The technological breakthrough could reduce retail prices for custom hearing aids by $500 to $800, or up to $4 billion annually. Combine lower prices with greater satisfaction, and it is not unreasonable to assume that the sale of hearing aids could double from 15 percent of potential users to 30 percent, a vast expansion of patient base to benefit this technology and an increase of almost $10 billion annually, bringing with it additional jobs and ripple-economic benefits. Non-medical fields to benefit this technology include cell phone headsets and entertainment industry - another multi-billion market.