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INTENDED USE: The passive middle ear implant - tympanoplasty total prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty total prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles totally. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition. INDICATIONS: The tympanoplasty prosthesis is indicated to treat patients with: - congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma) - inadequate conductive hearing from previous middle ear surgery The total ossicular replacement prosthesis is indicated, if at least the stapes footplate is present and functional. Tympanosplasty Sizers for total prosthesis INTENDED USE The tympanoplasty Sizers are intended to be used during a total ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis. The tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition. The Sizers for total prosthesis are intended to intraoperatively determine the distance between the footplate of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis. INDICATIONS The indications of the PMEI tympanoplasty total prostheses apply.

The MED-EL "Passive Middle Ear Implants" (PMEls) Tympanoplasty Total Prostheses are total ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. They are offered in different designs and fixed or adjustable functional length to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.

An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices: (i) Unalloyed titanium (ASTM F67) (ii) Titanium alloy (ASTM F136) (iii) Medical Grade Silicone (iv) ASTM F1185 Hydroxylapatite

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear. Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include. fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window. Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical qauge (code 02.14) The implant must be carried out by a qualified surgeon.

Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear. Otosurgical prosthesis of the middle hear, are manufactured from a wide variety of materials: titanium, poliethylene (PE), stainless steel, hydroxylapatite (HA). platinum (Pt). politetrafluoroethylene (PTFE), gold, polimetilxilossano (silicon) and Nitinol, or combination of these materials. Numerous designs are available for replacement of any or all of the bones of the ossicular chain.

An ossicular replacement prosthesis is a device intended to the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications for use include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and surgically correctible injury to the middle ear from trauma.

The family of Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses consists of: Grace Medical ALTO (Adjustable Length Total Ossicular) Prostheses Grace Medical ALPO (Adjustable Length Partial Ossicular) Prostheses Grace Medical FLTO (Fixed Length Total Ossicular) Prostheses Grace Medical FLPO (Fixed Length Partial Ossicular) Prostheses Silverstein ALTO (Adjustable Length Partial Ossicular) Prostheses with Footplate Tack Grace Medical Frisbee Myringopexy (Fixed Length Partial Ossicular) Prostheses. The Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses are manufactured from the same or similar materials as the predicate devices. The Grace Medical Adjustable-Length PORP's and TORP's contain a medical grade silicone sleeve fixed to the titanium shaft which allows for adjustment to length by the user. Various designs of Grace Medical Adjustable Length Partial & Total Ossicular Replacement Prostheses are available to meet physician preference.

The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

The FISCH Titanium Middle Ear Prostheses are made of anodized titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.

Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.

Titanium Ossicular Replacement System

The Lelbinger titanium ossicular chain reconstruction prostheses and accessories are used for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations. Titanium ossicular chain reconstruction prostheses are available for the following indications: Chronic otitis media Immobility of the stapes (otosclerosis in particular) Injury of the ossicle (trauma) Abnormal and defective formation of the middle ear Secondary procedure to improve hearing Revision operation on a malpositioned prosthesis

The system consists of various implants, instrumentation, and storage containers. Product Designation | Product Intended Use --------------------|--------------------- Stapes prosthesis | Flat band and piston prosthesis for attachment to the malleus or incus, inserted through the footplate of the stapes. Total prosthesis (TORP) | Plate prosthesis with shaft and shoe as ossicle replacement between the tympanic membrane and the footplate of the stapes. Neomalleus total prosthesis | Malleus prosthesis as ossicle replacement In combination with stapes prosthesis. - Incus prosthesis | Incus replacement to connect malleus and head of stapes. Partial prosthesis (PORP) | Malleus and incus replacement to connect tympanic membrane and head of stapes.

Otosclerosis. Congenital fixation of the stapes. When previous remedial surgery has been unsuccessful for the treatment of hearing loss due to otosclerosis, and a significant conductive loss remains with good cochlear reserve. Chronic middle ear disease. Trauma.

The Bojrab Micro-TORP Prosthesis is substantially equivalent to the Black Oval-Top TORP marketed by Smith & Nephew, Inc., ENT Division, and the Schwaber Total implant marketed by Xomed. These devices have the same indications for use, total reconstruction of the ossicular chain that has lost its function due to disease, trauma, or congenital defect. The head of the Bojrab Micro-TORP Prosthesis is made from Hydroxylapatite, a widely accepted material for middle ear reconstruction, as are the heads of the two predicate devices. The Bojrab Micro-TORP Prosthesis and the predicate devices all have trimmable shafts. The Bojrab and Black implant shafts are made from HAPEX and the Schwaber implant shaft is manufactured from FLEX H/A.

The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes. The treatment of an absent or defective stapes.

The Mills Columella Prosthesis is manufactured from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including loss of stapes arch.