Completely Digitizing the Custom-Fit Hearing Aid Shell Manufacturing Process

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.