Electronic Device Cleared by FDA to Treat Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a complex condition with a number of potential causes, symptoms, and treatment options. While experienced in the gut, IBS often seems to be related to a poorly functioning nervous system. Specifically, the signals that the gut sends can be perceived by the brain as being abnormal, resulting in sensations of pain and discomfort.

A new device called IB-stim from Innovative Health Solutions, a company out of Versailles, Indiana, just received FDA clearance to treat IBS by manipulating the electrical signals reaching the brain.

The device looks very similar to a hearing aid, but instead of processing sound, it uses three electrodes to deliver electrical impulses to the peripheral cranial nerve branches of the ear. These nerve bundles provide an efficient path into the regions of the brain that relate to pain perception. The artificial signals sent by the device seemingly disrupt signals coming from the gut, and the result is that there should be no sensation of pain.

This has been confirmed in a double blind, randomized, controlled clinical trial evaluating the IB-Stim versus a placebo. The patients in the study, 70% of whom did not respond positively to an average of four drugs, responded well to the IB-Stim. As a matter of fact, the treated group showed an 81% improvement in overall IBS symptoms while suffering from no serious adverse events and minimal, if any, side effects.