Safety and efficacy of the Bonebridge bone conduction implant: a comparative study

Abstract

Objective: We prospectively evaluated safety and clinical efficacy of an active bone conduction implant, named Bonebridge, in patients with conductive hearing loss (CHL). Performance was compared with the preoperative aided condition. Methods: Nine Dutch-speaking patients were implanted with Bonebridge in a single tertiary referral center and were followed up for 4 years and 11 months (mean). Six patients had CHL, one had mixed hearing loss (MHL), and two had single-sided deafness. Preoperatively, patients were fitted with a conventional air conduction hearing aid (HA) and/or a bone-anchored HA processor worn on a headband. Intra-and postoperative complication rates were assessed for all patients. Five patients with CHL/MHL participated in an extensive audiological evaluation, including regular measurements of hearing thresholds (air and bone conduction), speech reception in quiet (consonant vowel consonant or CVC words) and noise (sentences), and subjective satisfaction (Abbreviated Profile of Hearing Aid Benefit questionnaire and the Speech, Spatial and Qualities of Hearing Scale). Results: Patients' residual hearing was not deteriorated by the implantation, and no adverse events were reported. For CHL and MHL cases (n=5), the median functional gain was 20 dB at activation and remained stable thereafter. After 3 months, the median word recognition score in quiet at 40 dB A was 80%. The median speech reception threshold in noise was 4.8 dB signal to noise ratio 1 year postoperatively. Comparison with preoperative scores with a bone conduction device on a headband revealed no significant differences. Questionnaires demonstrated subjective satisfaction. Stable performance was observed along the entire follow-up period. Conclusion: Bonebridge can be considered a safe and effective treatment option for patients with CHL.