Objective: To investigate the safety and efficacy of a new bone conduction hearing implant in children, during a 3-month follow-up period.
Study design: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
Setting: Otolaryngology departments of four Austrian hospitals.
Patients: Twelve German-speaking children aged 5 to 17 suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 4000 Hz.
Intervention: Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI).
Main outcome measures: The subjects' audiometric thresholds (air conduction, bone conduction, and sound field at frequencies 500 Hz to 8 kHz) and speech perception (word recognition scores [WRS] and 50% word intelligibility in sentences [SRT50%]) were tested preoperatively and at 1 and 3 months postoperatively. The patients were also monitored for adverse events and they or their parents filled out questionnaires to analyze satisfaction levels.
Results: Speech perception as measured by WRS and SRT50% improved on average approximately 67.6% and 27.5 dB, respectively, 3 months after implantation. Aided thresholds also improved postoperatively, showing statistical significance at all tested frequencies. Air conduction and bone conduction thresholds showed no significant changes, confirming that subjects' residual unaided hearing was not damaged by the treatment. Only minor adverse events were reported and resolved by the end of the study.
Conclusion: Safety and efficacy of the new bone conduction implant was demonstrated in children followed up to 3 months postoperatively.