FDA.reportPublic FDA data

Fully-implantable middle ear implant system

Definition
An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the battery and processor unit, and an attached microphone and transducer that are fully implanted. The microphone receives sound waves that are converted into electrical signals which drive the transducer to vibrate the middle ear bones, stimulating the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.
GUDID devices
54
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10812282020228Esteem® Bone ScrewsEnvoy Medical Corporation17902014-09-24
10812282020235Esteem® Glasscock StabilizersEnvoy Medical Corporation17302014-09-24
10812282020242Esteem® Tapered Syringe TipsEnvoy Medical Corporation17252014-09-24
10812282020518Esteem® SyringeEnvoy Medical Corporation17102014-09-24
10812282020563Esteem® IS-1 Lead End CapEnvoy Medical Corporation14002014-09-24
20812282020225Esteem® Bone ScrewsEnvoy Medical Corporation17902014-09-24
00812282020009Esteem® SensorEnvoy Medical Corporation70102014-09-24
00812282020016Esteem® DriverEnvoy Medical Corporation75042014-09-24
00812282020023Esteem® DriverEnvoy Medical Corporation75042014-09-24
00812282020030Esteem® DriverEnvoy Medical Corporation75102014-09-24
00812282020047Esteem® SensorEnvoy Medical Corporation70042014-09-24
00812282020054Esteem® SensorEnvoy Medical Corporation70042014-09-24
00812282020078Esteem® Personal ProgrammerEnvoy Medical Corporation80012014-09-24
00812282020122Esteem® Commander™Envoy Medical Corporation60012014-09-24
00812282020139Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020146Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020160Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020177Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020184Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020191Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020207Esteem® Sound ProcessorEnvoy Medical Corporation20012014-09-24
00812282020214Esteem® Sound ProcessorEnvoy Medical Corporation20012014-09-24
00812282020252Esteem® MedCem®Envoy Medical Corporation16102014-09-24
00812282020269Esteem® MedCem®Envoy Medical Corporation16102014-09-24
00812282020276Esteem® MedCem®Envoy Medical Corporation16102014-09-24
00812282020283Esteem® MedCem®Envoy Medical Corporation16102014-09-24
00812282020290Esteem® Transducer ReplicaEnvoy Medical Corporation15102014-09-24
00812282020306Esteem® Transducer ReplicaEnvoy Medical Corporation15102014-09-24
00812282020313Esteem® Sound Processor ReplicaEnvoy Medical Corporation15002014-09-24
00812282020320Esteem® Laser ReflectorEnvoy Medical Corporation12502014-09-24
00812282020337Esteem® Ear Insert AssemblyEnvoy Medical Corporation12002014-09-16
00812282020344Esteem® Ear Insert AssemblyEnvoy Medical Corporation12002014-09-24
00812282020351Esteem® Ear Insert AssemblyEnvoy Medical Corporation12002014-09-24
00812282020368Esteem® EnvoyCem®Envoy Medical Corporation16402014-09-24
00812282020382Esteem® Driver ReplicaEnvoy Medical Corporation15102014-09-24
00812282020399Esteem® Sensor ReplicaEnvoy Medical Corporation15102014-09-24
00812282020405Esteem® Driver ReplicaEnvoy Medical Corporation15102014-09-24
00812282020412Esteem® Sensor ReplicaEnvoy Medical Corporation15102014-09-24
00812282020429Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020436Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020443Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020450Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020467Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020474Esteem® Intraoperative System AnalyzerEnvoy Medical Corporation30012014-09-24
00812282020481Esteem® Commander™Envoy Medical Corporation60012014-09-24
00812282020498Esteem® Commander™Envoy Medical Corporation60022015-01-15
00812282020504Esteem® Commander™Envoy Medical Corporation60022015-01-15
00812282020528Esteem® Sterile DrapeEnvoy Medical Corporation13002014-09-24
00812282020535Esteem® Laser Light GuideEnvoy Medical Corporation17202014-09-24
00812282020542Esteem® Surgical Tools KitEnvoy Medical Corporation12162014-09-24
00812282020559Esteem® Subdural Needle ElectrodeEnvoy Medical Corporation17402014-09-24
00812282020573Esteem® Laser Light GuideEnvoy Medical Corporation17202014-09-24
00812282020603Esteem MedCemEnvoy Medical Corporation16102018-07-17
00812282020610Esteem Intraoperative System AnalyzerEnvoy Medical Corporation32002018-03-28