A wearable device for the treatment of depression is now available by prescription in the United States. The device, developed by Swedish firm Flow Neuroscience, is marketed as an alternative to traditional antidepressant medications, which are taken by approximately one in six American adults. The device is priced in the four-figure range, which may affect its adoption among patients.
The headset is worn on the forehead for 30 minutes daily and is operated via an app. It delivers low-intensity electrical stimulation to the left frontal lobe of the brain, an area associated with mood regulation. Research indicates that individuals with depression often exhibit reduced activity and weaker neural connections in this brain region.
Flow received approval from the Food and Drug Administration (FDA) in December 2022. The device is part of a growing category of wearables designed to monitor, record, or stimulate brain activity. Other examples include Cognixion's modified Apple Vision Pro for communication assistance, Muse's headband for meditation enhancement, and Elemind's device aimed at improving sleep.
The Flow device targets the same brain region as transcranial magnetic stimulation (TMS), an established depression treatment that uses magnetic fields to stimulate neurons. TMS requires patients to visit a clinic for treatment, typically involving five sessions per week over several weeks, with total costs potentially reaching $15,000 without insurance.
Flow CEO Daniel Månsson, who has a background in clinical psychology, stated that the goal was to create a more convenient treatment option for patients. He emphasized the need for a device that effectively impacts the brain while being safe and usable at home.
In a clinical trial involving 174 participants with major depressive disorder, 45% of those using Flow’s device reported symptom remission after 10 weeks, compared to 22% in a control group receiving a sham device. The trial included both individuals on antidepressants and those not taking medication, suggesting the device may be used alongside traditional treatments, according to Månsson.
Reported side effects from the device were mild, including skin irritation, headaches, and difficulty concentrating. In contrast, common side effects of antidepressants can include nausea, weight gain, drowsiness, dry mouth, and sexual dysfunction, though these often subside after a few weeks of use.
In Europe, where the device has been available since 2019, over 65,000 individuals have utilized the Flow device, and the UK’s National Health Service is currently piloting its use.
In the US, patients can obtain a prescription for the Flow device from a clinician either in person or through telehealth services. However, they will need to pay out of pocket: $2,200 for a 10-week period and $325 per month thereafter, which is significantly higher than the cost of standard antidepressants typically covered by insurance. Månsson indicated that the company is working on obtaining insurance reimbursement.
Vinod Khosla, a venture capitalist and early investor in Flow, expressed support for nonchemical approaches to treating depression, suggesting that many individuals on antidepressant medications would prefer alternatives. "My bet is, if you ask any person who's on depression drugs, they'd prefer not to be on them," Khosla stated. "They'd like a nondrug, nonchemical treatment for it."