FDA Product Code ETN: Stimulator, Nerve

FDA product code ETN covers nerve stimulators used in otolaryngology and skull base surgery.

These devices deliver controlled electrical stimuli to identify and map cranial nerves intraoperatively — particularly the facial nerve during parotid, acoustic neuroma, and mastoid surgery — reducing the risk of permanent nerve injury. Real-time electromyographic feedback alerts the surgeon when the probe is near nerve tissue.

ETN devices are Class II medical devices, regulated under 21 CFR 874.1820 and reviewed by the FDA Ear, Nose & Throat panel.

Leading manufacturers include Medtronic Xomed, Inc., Nuvasive, Inc. and Neurovision Medical Products, Inc..