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

Inclusion Criteria:

22 years of age or older

• Unilateral facial palsy due to any of the following: Bell's palsy, Ramsay Huntsyndrome, malignant or benign tumor resection, Lyme disease, cerebrovascularaccident (hemorrhagic or ischemic), or trauma

• A deficit in eye closure during blinking, defined as a mean blink score ≤2.0 in thestudy eye on the scale by Mäkelä, et al, as graded by the investigator.

• Willing and able to comply with the study procedures and follow-up

• Willing and able to provide informed consent

• English, Spanish, or Hebrew, Arabic -speaking

• In a trial with the BlinkER System, the device produces blinks sufficient to coverthe pupil in the study eye, defined as a mean grade ≥ 3.0 on the Mäkelä scale, asgraded by the investigator.

• Participant successfully completes BlinkER System training and certification

Exclusion Criteria:

• Bilateral facial paralysis (for example Parkinson's Disease)

• History of prior intervention that is providing closure of the eyelids (e.g., facialreanimation, complete tarsorrhaphy surgery, etc.)

• Has an implanted eyelid weight in the study eyelid.

• History of diabetic neuropathy, unstable cardiovascular disease, neurologic diseasecausing severe cognitive or motor impairment, severe immunological deficiency, ormalignant diseases that are not in remission

• Signs of corneal infection, severe ocular surface inflammation, or significantperiorbital skin inflammation/infection

• Suspected or diagnosed epilepsy.

• Cancerous lesions in the area where the BlinkER system electrodes will be applied.

• Cardiac demand pacemaker, implanted defibrillator or other implanted electronicdevice

• Cornea or iris abnormalities that preclude visualization of the pupil

• Cranial nerve V palsy or neurotrophic keratitis

• Synkinesis that results in eyelid closure

• Known allergy to any of the patient-contacting materials of the BlinkeER electrode (i.e. polyethylene (PET) film tape or hydrogel)

• Participants who are pregnant or nursing.

• Participation in another ophthalmic clinical trial within one year prior toenrollment. Participant must also be willing to refrain from another ophthalmicstudy for the duration of the study.

• Co-existing condition, either ocular or non-ocular that, in the judgement of theinvestigator could affect the safety or effectiveness of treatment or the complianceof the participant to the protocol.