The goal of this program is to create a totally implantable stimulator device that can restore eye blink in patients with unilateral facial nerve paralysis. The system will record EMG from the intact eye to detect normal blink and stimulate the muscle of the paralyzed eye to create a synchronous blink. The implant will consist of a thin, ceramic package placed subcutaneously near the mastoid with a small number of surface electrodes sutured to the muscles placed with minimally-invasive facial endoscopy. In Phase I, the feasibility of the approach will be demonstrated by acutely stimulating the eye muscles of patients with facial nerve paralysis using transcutaneous electrodes. This study will confirm previous animal work in the area for human subjects and identify proper electrode placement and stimulation for functional and cosmetically acceptable eye closure. In Phase II, a fully implantable system will be developed for use in limited clinical trials with human subjects. The market for these devices is relatively small with annual patient populations on the order of a few thousand per year. For patients with chronic facial paralysis, however, the restoration of functional eye blink will provide a profound improvement in quality of life, and a reduction in the likelihood and costs of complications such as eye damage, infections and vision loss. ? ?
