Device typeOssicular prosthesis, partial: A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or 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 metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.
FDA categoryPOROUS POLYETHYLENE OSSICULAR REPLACEMENT
Device ID00681490035712
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
SizeHead Diameter is 3.0 MM
SizeShaft Inner Diameter is 1.17 MM
Length4.75 Millimeter