Safety & Precautions
Is Flow safe?
The Flow headset has been designed and extensively tested by experts. It is CE-certified and complies with all European and UK laws for medical devices. It has also received the Food and Drug Administration (FDA) Breakthrough Device Designation for at-home depression treatment in the United States.
The technology Flow uses is transcranial direct current stimulation (tDCS). tDCS has been used in clinical settings for decades, and its safety and performance has been evaluated in hundreds of clinical trials. To learn more about the safety and performance of Flow in these clinical trials, visit our Research page.
It is important to always use Flow in accordance with the user manual.
Who can use Flow?
If you're 18 or older and have been told by a doctor you have depression (mild, moderate or severe), Flow could work for you. Because of the way Flow works, it doesn’t interfere with medicines you may be taking and is generally safe to use if you have other medical conditions including diabetes, asthma, hypertension, are neurodivergent, or if you suffer with other mental health conditions in addition to depression.
If any of the following applies to you, talk with your doctor before using the headset:
- You are thinking of changing something about your current treatment, for example changing your antidepressant dosage
- You are unsure about your diagnosis
- You are pregnant, think you might be, or become pregnant while using Flow
- You currently have thoughts about suicide or harming yourself
- You have been told there is a problem with your skull or if you have metal parts in or around the brain, like brain surgery clips, metal plates or screws in the skull, cochlear implants or brain pacemakers such as those used for Parkinson’s disease. It is fine to use the device if you have dentures.
- You have epilepsy or have had seizures
- You have a chronic skin condition affecting your forehead, such as psoriasis
- You have bipolar disorder
What are the common side effects?
Over 20,000 people have used Flow and less than 5% have reported side effects1.
The most common side effects experienced are:
- Skin reactions (redness, irritation, itching, stinging, minor burns)
- Headache
- Tinnitus
- Worsened symptoms of depression including increased anxiety
- Tiredness, fatigue and general malaise including sleep disruption
These side effects typically resolve within a few hours to no more than a few days, and many users tend to adapt to the treatment over time, resulting in a reduction or disappearance of side effects with continued use.
Can Flow treat other conditions?
Flow is certified solely as a treatment for depression. Although it is deemed safe to use Flow for depression alongside other conditions such as obsessive-compulsive disorder (OCD), attention-deficit/hyperactivity disorder (ADHD), or post-traumatic stress disorder (PTSD), we strongly advise against using Flow for any purpose other than depression treatment.
More questions?
To find out whether Flow can help you, take the ‘Is Flow For Me?’ quiz. To learn more about side effects or to report a side effect you have experienced when using Flow, visit our Help Centre or contact our support team at support@flowneuroscience.com.
1Data reported February 2024. Users are encouraged to contact Flow support to report side effects. The Flow team is exploring ways to make it even easier to report side effects in order to increase representation from all users. Please note that Flow Neuroscience cannot offer clinical advice and you are recommended to discuss treatment and side effects with your doctor.