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INTENDED USE. The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition. INDICATIONS: The stapesplasty prosthesis is indicated to treat patients with: - congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear - inadequate conductive hearing from previous stapes surgery

The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus. They are offered in different designs, functional lengths and/or piston diameters 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.

INTENDED USE: The passive middle ear implant - tympanoplasty partial 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 partial prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. 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 partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional. Tympanoplasty Sizers for partial prosthesis: INTENDED USE: The tympanoplasty Sizers are intended to be used during a partial 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 partial prosthesis are intended to intraoperatively determine the distance between the head 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 partial prostheses apply.

The MED-EL "Passive Middle Ear Implants" (PMEI) Tympanoplasty Partial Prostheses are partial 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.

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.