According to statistics from National Institute on Deafness and Communication Disorders (NIDCD), more than 28 million Americans suffer from some type of hearing impairment. It is estimated that over 260 million people are hearing impaired worldwide. Fortunately, many of these people can benefit from the use of a carefully fitted hearing aid. Current manufacturing processes for custom-fit shells of hearing aids is a highly labor-intensive, manual process. Each shell has to be made by skilled technicians using manual operations. The quality and consistencies of the fitting vary significantly with the technician's skill level. A typical process of producing a shell takes about 40 minutes from start to finish. Major drawbacks of the manual process include shortage of skilled workers and a long training time, product variances - lack of consistency of quality, slow production that is not scalable for mass production, and a high level of product remakes and returns. The primary objective of this SBIR effort is to investigate the feasibility of an automatic shell manufacturing (ASM) process for custom-fit hearing aids based on a novel 3D camera technology invented by Genex Technologies, Inc (GENEX). We propose to develop a low-cost high precision 3D camera that is able to acquire the 3D digital models of an ear impression and incorporate the customer-specific 3D data into shell design software. The computer-aided design of the shell is then sent to a rapid prototyping machine to build the custom-made shell directly. We have completed a successful Phase 1 project that demonstrated the feasibility of a turnkey ear impression digitization system, interface with CAD design software, and streamline the Rapid Prototyping technique for fabricating shell pieces. Our Phase 2 program is geared toward further improve the technology and working closely with hearing aid manufacturers to develop and test field deployable prototypes.
