FDA Grants De Novo to Neurovalens' Modius Spero Headset for PTSD Symptoms

The US Food and Drug Administration has granted a De Novo request for Modius Spero, a headset that delivers low-level electrical stimulation behind the ears to treat symptoms of post-traumatic stress disorder, Neurovalens said in a May 26 release on its website.

The FDA's De Novo database lists the decision as DEN250013, granted on May 8, 2026, after the agency received the request on April 16, 2025. The Northern Ireland company said Modius Spero is the first neuromodulation device authorized by the FDA to treat symptoms associated with PTSD.

What the order covers

The classification order describes Modius Spero as a prescription, home-use device indicated for the treatment of symptoms associated with PTSD in adults aged 22 and older, for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional.

The order places it in Class II under a new generic type, the transcranial nerve stimulation device for PTSD-associated symptoms, with product code SHX. The FDA defines the type as an externally worn device that applies electrical stimulation to the head and is "not intended as a stand-alone therapy or to alter usual care treatment."

Risks the agency listed for the device type include ineffective treatment leading to sustained or worsening symptoms or delayed effective treatment, headache or migraine, vision impairment, tinnitus or vertigo, and injuries from device malfunction such as burns or skin discomfort. Special controls require clinical testing that evaluates changes in PTSD symptoms and all adverse effects, and labeling with a warning about physician monitoring for side effects and signs of worsening symptoms.

Trial results and VA rollout

Neurovalens said the De Novo grant followed a pivotal US trial led by Peter Colvonen of the University of California, San Diego. The trial enrolled 383 adults with clinical PTSD diagnoses, who received either the Modius Spero headset or an active sham device. According to the company, "two-thirds of participants using Modius Spero reported a clinically meaningful improvement in PTSD symptoms." These are company-reported results; the release did not give the scale used or the result in the sham group.

As reported by Psychiatric Times, the trial lasted 12 weeks and the device uses skin electrodes behind both ears in 30-minute daily sessions.

The company said Modius Spero will be available to veterans through the US Department of Veterans Affairs from this summer. Its Modius Sleep and Modius Calm devices are already offered exclusively to US veterans through the VA, the release said.

"We are especially proud that Modius Spero's first patients will be Veterans, supported through the U.S. Department of Veterans Affairs," said Jason McKeown, the company's chief executive.