An implantable hearing device: osseointegration of a titanium-magnet temporal bone stimulator

The use of bone conduction hearing devices has recently entered the realm of implantable prostheses and solid-state electronics, resulting in improved fidelity and applicability for a wider range of patients. One particular device, a temporal bone stimulator (TBS), consists of an external sound processor and implanted portion to cause vibration under the skin. An implantable temporal bone stimulator screw constructed of titanium alloy with a permanent magnet can be vibrated by inductive transcutaneous coupling. The safety and osseointegration of the TBS bone screw were tested in adult goats that were free-field stimulated at 75 dB with the TBS processor for 4 to 21 weeks. Histologic comparisons of the soft tissue and bone adjacent to active and passive screws revealed no remarkable differences between them with bone growing in the interstices of the threaded portion. Evidence for mild reorganization of bone was shown with Goldner's stain, which differentiated bone that was young and unmineralized from bone that was older and mineralized. Reorganization was evident in both the active and passive sites and there was no remarkable difference between the two in a blind study. Additional evidence for the integrity of the implant was obtained by subjecting a calvarium containing both screws to a 5000 gauss magnetic field for 10 minutes of a nuclear magnetic resonance head scan. The calvarium was first dissected free from overlying skin and connective tissue. The magnet-containing screws were not loosened. We conclude that the implanted screw portion of the TBS implantable hearing device is well-integrated into the temporal bone. Mild stimulation of new bone growth indicates a healthy long-term viable implant for bone conduction amplification of sound.