FDA Approves Neurolief's ProlivRx Headset for At-Home Depression Treatment

The US Food and Drug Administration has approved Neurolief's ProlivRx System, a prescription headset that delivers mild electrical stimulation to nerves at the back of the head and in the face, as an add-on treatment for major depressive disorder that can be used at home, the company announced on January 12 in a release distributed by PR Newswire.

The FDA's premarket approval database lists the device as P250010, classed as a cranial electrotherapy stimulator to treat depression. The agency received the application on March 26, 2025, and approved it on December 31, 2025. It is indicated as "an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic," and is a prescription-only device.

Neurolief calls the therapy external Combined Occipital and Trigeminal Afferent Stimulation, or eCOT-AS, and described ProlivRx as the first prescription, physician-directed, at-home brain neuromodulation therapy for this group of patients; that is the company's claim.

What the MOOD trial showed

According to the FDA's summary of safety and effectiveness data, the approval rests on the MOOD study, a randomized, double-blind, sham-controlled trial at 12 US sites and one in Israel. Of 126 randomized participants, the main analysis included 97 (47 active, 50 sham) who used the device for at least 40 minutes a day, five days a week, for eight weeks without major protocol deviations.

Scores on the 17-item Hamilton Depression Rating Scale fell 8.62 points in the active group and 6.01 points in the sham group, a 2.61-point difference that was statistically significant (p = 0.0196), meeting the primary endpoint. Remission at eight weeks was 21.3% with active treatment and 6.0% with sham, and response was 31.9% against 18.0%. The FDA summary says that across all secondary endpoints the device arm showed a numerical advantage but did not meet the p < 0.05 criterion after adjustment for multiple comparisons.

The agency also listed limits. It said there is "a moderate level of uncertainty of benefit" because there is no consensus on what between-group difference in the Hamilton scale is clinically meaningful and the study had no prespecified clinical significance threshold. It added that blinding was assessed only at baseline and that durability is uncertain because the study was unblinded at eight weeks. Improvements in an eight-week open-label extension could not be separated from a placebo effect, the summary said.

Launch plans

Neurolief said it expects ProlivRx to be available in the US in early 2026 through authorized prescribers, initially through health systems, behavioral health programs and integrated care settings.

"Proliv™Rx was developed to extend brain neuromodulation beyond the limitations of traditional clinic-based care," said Scott Drees, Neurolief's chief executive, in the release.

Linda Carpenter, a principal investigator of the trial and professor of psychiatry at Brown University, said in the release that patients with difficult-to-treat depression had not had a non-drug option that could be used at home. Trade outlet HCPLive reported that the trial ran from September 2021 to June 2024 and enrolled adults aged 22 to 70.