Lifetime Real-World Evidence on Safety and Performance of the First Active Transcutaneous Bone Conduction Implant (BCI), the Bonebridge Covering Conductive to Mixed Hearing Loss (CMHL), and Single-Sided Deafness (SSD): Results From a Long-Term Retrospective Analysis

OBJECTIVE: Confirm the safety and performance of the first partially implantable active transcutaneous Bone Conduction Implant (tBCI) in patients who have been implanted for a minimum of 5 years before 2023.

SETTING: Otolaryngology departments of 4 German and Austrian hospitals.

STUDY DESIGN: Retrospective, multicenter, longitudinal, open-label case series study. Patients: 186 ears treated for conductive and mixed hearing loss (CMHL), or single-sided deafness (SSD) implanted for 5 years (151 aged 18 y or older, 35 aged 5 to 17 y) at the time of implantation.

INTERVENTION: Implantation of the Bonebridge (BB) BCI 601, a partially implantable active middle ear implant (AMEI).

MAIN OUTCOME MEASURES: Patients' audiometric pure-tone average (PTA4) (0.5, 1, 2, 4 kHz) thresholds (bone conduction, sound field) and speech perception (word recognition scores) were retrospectively collected up to 10 years 10 months postoperatively. Complications were recorded with focus on revision surgery and explantations. Subgroups were adults and children.

RESULTS: Safety was established by stable bone conduction (BC) thresholds 5 years after implantation or later with mean paired differences of -5.33 dB for adults and -8.05 dB for children and underscored by a low number of technical failures and high survival rates 10 years after implantation. Paired mean sound field PTA4 thresholds and word recognition scores significantly improved as tested by post hoc analysis 5 years or later after implantation, with functional gains for CMHL of 23.44 dB (adults), 27.69 dB (children), and word recognition scores of 58.22% (adults), 80.00% (children). Furthermore, mean sound field PTA4 thresholds and word recognition scores remain significantly improved over time at 36.37 dB HL and 68.75% 5 years or later after implantation as tested with linear mixed-effects model.

CONCLUSIONS: The findings of this study demonstrate that this tBCI remains safe and effective for up to 10 years.