Published on: 2023-00008. Final amendment; final order. 2023-00008. Medical Devices; Ear, Nose, and Throat Devices; Classification of the Powered Insertion System for a Cochlear Implant Electrode Array
Published on: 2019-27394. Final amendment; final order. 2019-27394. Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Published on: 2019-23464. Final order. 2019-23464. Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Published on: 2018-23412. Final order. 2018-23412. Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System
Published on: 2016-25602. Final order. 2016-25602. Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System