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KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing. Specifically, the devices are designed for the treatment of 1. Chronic middle ear inflammation (also following removal of a tumour, e.g. cholesteatoma) with functional impairment of the ossicular chain 2. Otosclerosis (stapedial fixation) / congenital stapedial fixation 3. Traumatic injury to the ossicular chain 4. Malformation of the middle ear 5. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis

Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing. NiTiFLEX Stapes Prosthesis: The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain. It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67). The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved. Detroit Piston: The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop. Roberson Stapes Prosthesis: The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device). Skarzynski Piston: The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.

The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear. The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium. Specifically, the devices are designed for the treatment of - Otosclerosis (stapedial fixation) / congenital stapedial fixation 1. - 2. Traumatic injury to the ossicular chain - 3. Malformation of the middle ear - Revision surgery to correct inadequate hearing improvement, e.g. through dislocation 4. of a prosthesis

The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67). The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. The ContactFree Zones serve as heat blockers, limit heat dispersion on the mucosa and minimize the risk of incus stranqulation. The prosthesis comes with an accessory, the Thermo-Dummy®, to predetermine the lowest laser setting that will close the prosthesis loop outside the patient's ear before inserting the implant.

Temporary implant for ventilation and drainage of middle ear. Temporary implant for ventilation or drainage of the middle ear.

The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.

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.

KURZ Silicone Strips are placed over the tympanic membrane after surgical procedures in the middle ear to reduce the risk of adhesion to the surgical packing and to aid in the prevention of canal granulation and polyp formation. KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.

KURZ Silicone Strips are manufactured from a medical grade silicone elastomer cut to size specifically for use within the external ear canal following ear surgery. The pliable, soft consistency of the silicone strips adapts itself to the shape of the auricular canal without further shaping by the physician, which saves valuable time in the operating room. KURZ Silicone Strips are intended for single use and are provided sterile. They require no further processing. They will be supplied transparent, white or transparent with blue stripes. Application, use and technical characteristics of the three presentations are identical. Choice of one or the other is entirely a matter of personal preference of the operating surgeon. Some surgeons prefer the transparent silicone strip, since the healing process can be checked without removing the dressing. Others prefer the white silicone strip, since they find it easier to see and handle. The transparent strips imprinted with blue stripes combine both advantages. The healing process can be observed through the transparent parts of the silicone, while the blue stripes make the silicone strips easily visible.

For bridging the stapes in case of otosclerosis;

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a conventional KURZ piston shaft.

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.

The all-titanium prosthesis consists of a clip with seven (7) resilient prongs, a shaft, and a head plate.