The cochlear implant program: an overview.

The single-electrode cochlear implant used at the House Ear Institute is undergoing clinical trials under Food and Drug Administration regulations governing medical devices. The program involves selection and evaluation of suitable subjects, surgery, basic guidance or training in implant use, and regular follow-up. As of November 1, 1981, 199 deaf subjects have had cochlear implant surgery. They range in age from 3.5 to 75 years old. Subjects with a wide variety of etiologies have been successfully implanted. The vast majority use their device on a daily basis, and subjects as a group have received more than 800,000 hours of electrical stimulation. Fifteen other otologists in the United States have implanted one or more subjects as coinvestigators in this clinical trials program. The otologists and their implant teams are trained by the House Ear Institute. Results indicate that the implant program can be performed adequately in a variety of clinical settings.