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News From the Food and Drug Administration
July 16, 2019

Cranial Nerve Stimulator for Adolescents With IBS

JAMA. 2019;322(3):199. doi:10.1001/jama.2019.9477

The FDA has authorized marketing of the first medical device for adolescents with abdominal pain associated with irritable bowel syndrome (IBS). The device, which is available by prescription only, is indicated for patients aged 11 through 18 years.

Research suggests abnormal communication between the brain and gut is involved in IBS-related functional abdominal pain. The approved IB-Stim device targets the brain-gut axis by modulating pain pathways in the central nervous system with low-frequency electrical stimulation of peripheral cranial nerves beneath the skin. Worn behind the ear, the single-use, battery-powered stimulator is replaced after 5 days of continuous use. Patients can use the device for up to 3 consecutive weeks.