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

Exclusion Criteria

• •Bilateral facial paralysis (for example Parkinson's Disease)
• •History of prior intervention that is providing closure of the eyelids (e.g., facial reanimation, complete tarsorrhaphy surgery, etc.)
• •Has an implanted eyelid weight in the study eyelid.
• •History of diabetic neuropathy, unstable cardiovascular disease, neurologic disease causing severe cognitive or motor impairment, severe immunological deficiency, or malignant diseases that are not in remission
• •Signs of corneal infection, severe ocular surface inflammation, or significant periorbital 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 electronic device
• •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 to enrollment. Participant must also be willing to refrain from another ophthalmic study for the duration of the study.
• •Co-existing condition, either ocular or non-ocular that, in the judgement of the investigator could affect the safety or effectiveness of treatment or the compliance of the participant to the protocol.