About two weeks ago, the U.S Food and Drug Administration (FDA) approved marketing of the IB-Stim device, for use in adolescents, ages 11-18, with functional gastrointestinal pain related to irritable bowel syndrome (IBS).
IB-Stim, developed by Innovative Health Solutions in Indiana, is a small nerve stimulator device powered by a battery and intended to be worn behind the ear. The FDA approval was based on a randomized, double-blind clinical trial of 50 youth in the approved age range. According to Innovative Health Solution’s results, 81% of the study participants in the IB-Stim group experienced a reduction in symptoms with minimal or no side effects. Reportedly,70% had previously not obtained adequate relief with an average of four medications.