EMPOWER AUD Pivotal Trial

To evaluate the safety and effectiveness of the Empower Neuromodulation System in alcohol use disorder (AUD) patients. The primary safety endpoint will be device-related serious adverse events. The primary effectiveness endpoint will be responder rate at 12 weeks, where a responder is defined as a subject who experiences at least a one level reduction in the WHO risk level for daily alcohol consumption from Baseline to Week 12 as measured via the 28-day Timeline Follow-back (TLFB). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.