FDA Approves Neuromodulation Device to Treat PTSD Symptoms

The FDA granted de novo approval for a neuromodulation device to treat symptoms associated with post-traumatic stress disorder (PTSD), maker Neurovalens announced Tuesday.

The wearable, non-invasive device — dubbed Modius Spero — uses electrical vestibular system stimulation to target specific brain areas. It is prescribed and overseen by a healthcare professional as part of a comprehensive PTSD care plan.

Indicated for adults 22 and older, the at-home therapy involves daily 30-minute sessions via skin electrodes behind both ears. Patients can read, watch TV, or engage in other activities during treatment.

“The effects of PTSD can be devastating to people living with the condition,” said Neurovalens CEO Jason McKeown, MD, PhD, in a press release. “This medical device approval marks a turning point for the millions of people living with the condition who deserve better access to safe, effective, and non-invasive care.”

Underpinning the FDA approval was a sham-controlled clinical trial that randomized 383 participants with a clinical PTSD diagnosis. During the 12-week study, two-thirds of participants who used the Modius Spero headset reported a clinically meaningful improvement in PTSD symptoms, Neurovalens said.

PTSD is a common psychiatric disorder stemming from exposure to traumatic events, leading to symptoms that may include hypervigilance, flashbacks, insomnia, and self-destructive behaviors. It affects an estimated 13 million Americans annually and disproportionately impacts military veterans due to increased exposure to combat or life-threatening situations.

Current PTSD therapies include trauma-focused psychotherapies, antidepressants, and sleep aids. Treatments like transcranial magnetic stimulation and cranial electrotherapy stimulation are also used off-label.

The initial rollout of the Modius Spero device will target veterans through the Department of Veterans Affairs (VA) starting this summer. Two other Neurovalens devices — Modius Sleep for chronic insomnia and Modius Calm for generalized anxiety disorder — also are available to veterans through the VA network.