Wearable Device Approved to Help Manage PTSD Symptoms

Modius Spero, a non-invasive device for PTSD, received FDA clearance via the De Novo pathway.

May 27, 2026

Key Highlights

Modius Spero uses low-level electrical stimulation behind the ears to target brain pathways associated with PTSD.
The device is non-invasive, drug-free, and intended for use at home under clinician supervision, with daily 30-minute sessions.
FDA approval was based on a clinical trial involving 383 adults diagnosed with PTSD, showing promising results.

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.

About the Author

Daniel Beaird

Head of Content and Editor-in-Chief

Daniel Beaird is Head of Content and Editor-in-Chief of Healthcare Purchasing News (HPN), where he leads editorial strategy and content development across print, digital, podcasts, webinars, and educational programming. His coverage focuses on healthcare supply chain, sterile processing, infection prevention, and perioperative services, connecting industry developments with the purchasing and operational decisions that shape patient care.

Before joining HPN, he served as Senior Editor of The Journal of Healthcare Contracting, covering health system supply chain strategy, industry partnerships and the evolving business of healthcare.

He holds a bachelor’s degree in journalism from the University of Georgia and is based in Atlanta.