Safety and Effectiveness of the BlinkER System in Participants With Facial Nerve Palsy

Prospective, single-arm, multicenter, single-masked, pivotal study to Evaluate the Safety and Effectiveness of the Blinker system in Participants with Facial Nerve Palsy.

A single-arm, multicenter study will be conducted to evaluate the safety and effectiveness of the Blinker system in achieving eyelid closure over a 3-month period in individuals with facial nerve palsy. The study aims to enroll at least 80 participants for evaluation. Participants will use the investigative device for a duration of 3 months. All subjects will undergo the following visits: Screening/Baseline (Day 0), Day 1, Week 1, Week 2, Month 1, Month 2 (Remote visit), and Month 3. The inclusion criteria for participants will be unilateral facial palsy due to conditions such as Bell's palsy, Ramsay Hunt syndrome, malignant or benign tumor resection, Lyme disease, cerebrovascular accident (hemorrhagic or ischemic), or trauma. The estimated total study duration is 12 months.