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FDA Clears Ear Device for IBS Pain - Pain News Network


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FDA Clears Ear Device for IBS Pain  Pain News Network

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The U.S. Food and Drug Administration has cleared for marketing the first medical device to treat abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS).

The IB-Stim device is made by Innovative Health Solutions and is only available by prescription. It uses neuromodulation to stimulate cranial nerves around the ear to provide relief from IBS, a condition affecting the large intestines that causes abdominal pain and discomfort during bowel movements.

The battery powered device is placed behind the patient’s ear — much like a hearing aid — and emits low-frequency electrical pulses that disrupt pain signals. It is intended for use up to three consecutive weeks.  

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” said Carlos Peña, PhD, director of the FDA’[s Office of Neurological and Physical Medicine Devices.

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