Device typeOssicular prosthesis, total: A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of polymers.
FDA categoryREPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE
Device ID00763000913687
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional