FDA 510(k) Ear, Nose & Throat Devices

FDA 510(k) Ear, Nose, Throat Devices - Regulatory Overview

FDA 510(k) ear, nose and throat (ENT) devices cover diagnostic and therapeutic equipment used in otolaryngology. The FDA review panel code is EN.

This category includes:

• Hearing aids and amplifiers - air conduction, bone conduction and CROS systems
• Cochlear implants - Class III devices (typically PMA, some 510k predicate paths)
• ENT endoscopes - rigid and flexible nasopharyngoscopes, laryngoscopes
• Surgical instruments - microdebriders, powered ENT systems
• Audiometric systems - audiometers, tympanometers, OAE devices