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FDA Registration: Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Measuring Gauge (FDA Code: ), ENT Forceps (FDA Code: ), ENT Surgical Tray (FDA Code: ), Incus and Stapes Ossicular Prosthesis, Total Ossicular Replacement Prosthesis (FDA Code: ), Non-Sterile Prosthesis Modification For Ossicular Replacement Surgery Instrument (FDA Code: ), ...
Ossicular prostheses are commonly placed in patients with ossicular destruction or disruption due to cholesteatoma, chronic otitis media, or congenital ossicular malformation. Autografts were initially used for ossicular chain reconstruction due to their biocompatibility and good sound conduction.
Ossicular Replacement Prostheses | Radiology Key
Replacement prostheses can be divided into three types: Autograft, homograft (or allograft) and synthetic. Autografts are derived from the same patient and are usually obtained from the temporalis fascia, auricular cartilage (conchal or tragal) or the patient's own remaining ossicles. Homografts (or allografts) are obtained from other individuals of the same species but with a different genetic makeup. Disadvantages of homografts are the possibility of disease transmission1, biocompatibility, rejection and are more likely to become displaced. Homograft eardrums with complete ossicular chains have been used in the past to reconstruct severely damaged tympanic membranes and middle ears.1 Synthetic prosthesis are readily available, are presculptured and easy to use. However, they can have difficulties with displacement and extrusions. This was common with the porous polyethylene prostheses which were inserted in the early 1980s, that had a five year success rate as low as 22%.2 Newer prostheses using biocompatible materials, such as hydroxyapetite3 titanium4, have much higher success rates. Extrusion of synthetic prosthesis can be lowered by the placement of bone or cartilage between the eardrum and the prosthesis.