To investigate safety and efficacy of a new transcutaneous bone conduction hearing implant, over a 3-month follow-up period. Prospective, single-subject repeated-measures design in which each subject serves as his/her own control. Departments of Otolaryngology at 4 hospitals in Germany and Austria. Subjects were 12 German-speaking adults who suffered from conductive or mixed hearing loss. The upper bone conduction threshold limit was set to 45 dB HL at frequencies between 500 Hz and 4 kHz. Implantation of a transcutaneous bone conduction hearing implant. Subjects' speech perception (word recognition scores and SRT 50%) and audiometric thresholds (air conduction, bone conduction and sound field at frequencies 500 Hz to 8 kHz) were assessed preoperatively, 1 month postoperatively and 3 months postoperatively. The subjects were monitored for adverse events and given a questionnaire to assess their satisfaction levels. Speech perception as measured by word recognition scores and SRT 50% improved on average about 78.8% and 25 dB HL, respectively, 3 months after implantation. Aided thresholds also improved postoperatively at all tested frequencies and continued to improve from 1 to 3 months postoperatively. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not deteriorated by the treatment. Only minor adverse events were reported and resolved by the end of the study. The new transcutaneous bone conduction implant was demonstrated to be safe and effective in adults up to 3 months of device use.
1 April 2005 in Otolaryngology–Head and Neck Surgery
To evaluate the assessment of the internal auditory canal and the labyrinth in relation to different CI magnet positions and MRI sequences at 3 T. The indication criteria for cochlear implantation have been changed over the years and the growing number of implantations in patients after acoustic neuroma resections underline the importance of a postoperative MR imaging to assess the internal auditory canal (IAC) and the labyrinth. The MRI artifact induced by the cochlear implant magnet is a known problem that should be further observed by this investigation. We compared the artifacts of Cochlear 512 magnets at different head positions in vivo at 3 T. The observed positions varied with a nasion-external ear canal angle of 90, 120, and 160 degrees and a variable distance of 5, 7, and 9 cm in relation to the external ear canal and different MRI sequences. The complete assessment of the internal auditory canal and labyrinth was possible with a magnet positioned at 90 degrees and 9 cm and 160 degrees and 9 cm. Evaluation of the IAC alone was possible with magnet positions at 90 degrees and 7 cm and 9 cm, 120 degrees and 9 cm, and 160 degrees and 7 cm and 9 cm. A high-resolution 3D T2w Drive sequence decreased the visibility of the structures significantly. A high-resolution TSE 2D T2w sequence together with one of the above-described positions allowed sufficient visualization of the structures. The position of the implant and the MRI sequence used determine the assessment of the IAC and the labyrinth at 3 T MRI. A position of the implant magnet at a nasion-external auditory canal angle which is more horizontal and posterior than so far commonly used allows a better visualization of the IAC and the labyrinth at 3 T.