FDA authorizes Neurovalens' Modius Spero, the first neuromodulation device for PTSD
The headset stimulates the vestibular nerve behind the ear; 66% of 383 trial participants had a meaningful drop in PTSD symptoms at 12 weeks.
The FDA has granted De Novo authorization to Neurovalens’ Modius Spero, the first neuromodulation device authorized to treat PTSD symptoms. The head-worn device delivers gentle electrical pulses to the skin behind the ear, stimulating the vestibular system and, through it, deeper brain regions involved in stress and fear. In a US trial of 383 adults, 66% had a clinically meaningful reduction in PTSD symptoms at 12 weeks. The company says it will be available to veterans through the VA from summer 2026.
Neurovalens has used the same platform for insomnia and weight management.
Learn more: Neurotechnology · Neurovalens