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. ? ?
