Wearable Device Approved to Help Manage PTSD Symptoms

The FDA has granted De Novo approval to Neurovalens’ Modius Spero, making it the first FDA-authorized neuromodulation device designed to treat symptoms associated with post-traumatic stress disorder (PTSD). The wearable headset uses low-level electrical stimulation behind the ears to target brain pathways linked to PTSD symptoms.

The approval was based on a U.S. clinical trial involving 383 adults diagnosed with PTSD. According to Neurovalens, the therapy is non-invasive, drug-free, and intended for home use under clinician supervision, with patients completing daily 30-minute treatment sessions.

Neurovalens said Modius Spero will initially be available to U.S. veterans through the Department of Veterans Affairs later this summer. The company noted the device is intended to support, and not replace, clinician-directed PTSD care plans.

The company also markets other FDA-cleared neuromodulation devices focused on conditions including insomnia and anxiety.