The middle ear plays a crucial role in the quality of hearing. This complex construct performs different tasks like the protection against large air pressure input, the transmission of sound and its adaption to the inner ear impedance. Traumas, erosion by chronic otitis media or cholesteatoma, as well as other degenerative or damaging diseases, are reasons for a necessary reconstruction of specific middle ear structures. The reconstruction of the ossicular chain is very often performed by using rigid ossicular replacement prostheses made out of titanium, ceramics or bone. Tilting and dislocation of these passive implants are some of the known complications after middle ear surgery. They are related to loads at the implant coupling points in response to a tension change in the middle ear. The healing process, scar tension and ventilation problems are possible causes.
To increase the sound transmission quality of total reconstructions and safety in case of pressure dependent movement of the tympanic membrane, a novel flexible total ossicular replacement prosthesis (TORP) with a silicone coated ball joint prototype was developed and investigated. Besides measurements of first middle ear transfer functions of temporal bones, the mechanical properties of the flexible TORP were examined with stress relaxation investigations.
The novel silicone coated ball and socket joint TORP provides a sound transfer equivalent to the intact human middle ear at normal pressure and negative pressure in the middle ear. Together with the low stiffness values at an anatomically typical deflection of about 500 μm the prevention of a stiffening of the stapes annular ligament could be approved. Thus, improved acoustic transmission quality and reconstruction stability in comparison to common rigid titanium TORP could be determined. Nevertheless, further design improvements should be accomplished. The demonstrated flexible TORP can solve some common problems in middle ear reconstruction.