Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

Inclusion Criteria: * Male or female, 18-65 years of age * Documentation on initial TBI (defined as closed-head, non-penetrating, blunt, whiplash, or explosive blast-induced brain injury) severity (at time of injury): Glasgow Coma Scale (GCS) score 9-15, with loss of consciousness \< 24 hours, post-traumatic amnesia ≤7 days, or hospital admission ≤ 7 days post TBI * If female, subject is not pregnant, not lactating, has a negative pregnancy test prior to receipt of the PoNS™ device, and agrees to use contraception from screening to end of the study * Balance disorder with SOT composite score at least 16 points below normal resulting from a mild/moderate TBI without any concomitant pathologies * At least 1 year post injury * Stable neurologic status * Prior participation in a focused physical rehabilitation program for TBI and deemed by their treating clinician/themselves to have reached a plateau * Able to walk continuously on a treadmill for 20 minutes, level grade and at any speed, with support if needed * Access to a treadmill and commitment to utilize this for the at-home portion of the study * Able to understand the study procedures and give informed consent * Willing and able to adhere to the study schedule * Willing to complete a neuropsychological evaluation prior to inclusion Exclusion Criteria: * Medical finding from screening history and physical examination that is clinically significant or would otherwise impact patient safety or data integrity * Medical findi…