Assessment of Temporal Bone Thickness for Implantation of a New Active Bone-Conduction Transducer.

Objective: To investigate the minimum bone thickness in adults and children in the area of the skull affected by implantation of a new bone conduction device in patients without known medical history that indicates anatomical malformations.

Study Design: Retrospective, non-interventional study on computer tomography (CT) scans on file at a university medical center.

Study Methods: A digital model of the new bone conduction implant was virtually implanted in 3D reconstructions of temporal bones based on 197 CT scans, 132 from adults and 65 from children (evenly distributed in five different age groups). The bone thickness was measured in a total of 11 designated positions; five measurement points for the transducer (recess area), and six for the fixation screws, corresponding to three different positions for the fixation band holding the implant in place (screw area).

Results: The minimum bone thickness in the combined recess and screw area for adults was 5.55 ± 1.46 mm, with a 95% CI of 5.30 to 5.80 mm. For children, the thickness was 4.34 ± 2.29 mm (95% CI: 3.77-4.91 mm), increasing from 1.92 mm (0-4 yr) to 6.41 mm (12-14 yr). For all ages, the bone in the recess area was generally thicker compared with the screw area.With an implantation depth of 3 mm the transducer fitted in all of the adult temporal bones (100%) and 99.2% (131/132) of the adults had a bone thickness of at least 2.7 mm in all six measured screw positions. In all children from the age of 5 the transducer fitted at an implantation depth of 3 mm, and in all children from the age of 9, the fixation screws fitted at a depth of 2.7 mm. In all CT scans except for a 6-month-old child the new bone conduction device could be implanted in at least one of the fixation band positions analyzed.

Conclusions: In adults and many children without known medical history that indicates anatomical malformations, the average minimum bone thickness was thicker than both the maximum transducer depth of 3 mm and the 2.7 mm bone involvement of the osseointegrating fixation screws. The results indicate implant fit of the new bone conduction implant in all adult patients. The risks of compromising the sigmoid sinus and the dura as considered with larger implants are thus significantly reduced. Preoperative planning with CT would still be recommended for children below 9 years old.