The efficacy and safety of Nerivio have been extensively studied in more than 15,000 migraine patients in 14 studies to date. Nerivio is the only FDA-cleared migraine device that is worn remotely from the patient’s head and neck; therefore, it is remote from migraine pain.

In the migraine prevention clinical trial, no device-related side effects were experienced for those using Nerivio every other day for two months of the study (Tepper et al., Headache, 2023).

In the acute migraine treatment clinical trial, 96.4% of the patients did not report any device related side effects. Reported side-effects were local to the arm, not serious or severe, and temporal (Yarnitsky et al., Headache, 2023).

Medical devices intended for home or clinical use undergo rigorous testing, including ESD testing, to ensure they can operate safely and effectively under various conditions, including those where they might be exposed to static electricity.

The FDA uses different regulatory terms for medications and medical devices. The equivalence of FDA-approved medications for medical devices is FDA clearance.

Using the Nerivio should not be painful. When treating, you should set the treatment intensity level by increasing it to a level that feels strong yet comfortable and not painful. If the sensation is uncomfortable or painful, decrease the intensity by 1 or 2% or until strong but comfortable.

The Nerivio wearable should be used only during the 45-minute acute or preventive treatment. Remove Nerivio from your arm after each use and replace the protective film to maintain the stickiness of the electrodes.

A study has shown that patients who use Nerivio regularly for over one year gain stable efficacy throughout the year, making Nerivio an advantageous non-drug option for long term management of migraine (Synowiec et al., Advances in Therapy, 2023).

Nerivio does not have a daily limitation of use. The treatment duration for Nerivio is 45 minutes. If you have been treated with Nerivio and have not experienced relief, or the migraine has returned, you may perform additional treatments on the same day.

People with sensitive skin may experience a rash or redness of the skin under the electrodes using Nerivio.

Nerivio should not be used over skin conditions such as open wounds or rashes, swollen, red, infected, or inflamed areas, skin eruptions, or fragile skin on the upper arm at the treatment location.

The Nerivio device does not emit ionizing radiation. It used standard low-energy RF Bluetooth communications and was tested to comply with safety regulations, including emissions.

The Nerivio device does not deliver electric shocks. Nerivio uses Remote Electrical Neuromodulation (REN) to deliver low-amplitude electrical pulses through the wearable device placed on the upper arm. You can control the intensity of the stimulation via the smartphone app. The sensation feels like tingling and should not be painful or feel like an electric shock.