Audio-Visual Neuromodulation for Neuropathic Pain

This evidence review addresses prescription digital therapeutics (PDTs) that deliver therapeutic benefit through audiovisual (AV) hardware-software systems indicated for the management of neuropathic pain. Unlike software-only PDTs, the products reviewed here require dedicated hardware, a wearable AV stimulation device, through which proprietary software delivers the primary therapeutic intervention. To be within scope, a product must: 1) be a PDT in which software performs one or more medical purposes as the primary therapeutic component of a hardware-software system, excluding software used solely to store or transmit medical information; 2) have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA); and 3) be prescribed by a healthcare provider.