Device typeFully-implantable middle ear implant system: 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.
FDA categoryImplant, Hearing, Active, Middle Ear, Totally Implanted
Device ID00812282020320
Catalog number901250-002
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Unsafe