Device typeBone-conduction hearing implant system sound processor/vibrator: An electrically-powered, external device intended to compensate for impaired hearing by receiving sound waves from the environment and converting them into vibrations, which are transmitted to the inner ear via the temporal bone. It typically incorporates a microphone, transmitter/receiver and vibrator connected or magnetically coupled to vibrating implantable components (e.g., vibration transmission screw, partially-implantable abutment) for retention and transmission of vibrations to the inner ear; it may include positioning and protection devices. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.
FDA categoryHearing aid, bone conduction
Device ID09321502078948
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information