OTC Device HeadaTerm 2 Cleared for Prophylactic Treatment of Episodic Migraine

The Food and Drug Administration (FDA) has cleared WAT Medical’s HeadaTerm 2 as an over-the-counter (OTC) wearable transcutaneous electrical nerve stimulation (TENS) device for the prophylactic treatment of episodic migraine in patients 18 years of age and older.

HeadaTerm 2 is a rechargeable TENS device that adheres to an individual’s forehead and releases targeted electrical impulses to increase pain tolerance. The device acts on the supraorbital nerve and supratrochlear nerve, the nerves that transmit migraine pain. The simplified design allows the user to control the device with one button.

The clearance was supported by data from previously approved anti-migraine OTC TENS devices (eg, Cefaly), as well as data from a randomized, double-blind controlled study that compared the effectiveness of TENS therapy to sham in 151 patients who were admitted to the emergency department for acute migraine. 

Efficacy was measured using the visual analog scale (VAS), as assessed by the patients’ perceived changes in pain intensity at 20 and 120 minutes after initiation. The mean VAS change from 0 to 120 minutes was reported to be  -65 ± 25 for the TENS group and -9 ± 2 for the sham group (P <.001). 

Additional clinical studies using the HeadaTerm2 are expected to commence in 2024. The device is available without a prescription and can be ordered at www.emeterm.com and on Amazon. It retails for $99.99.