The Bonebridge BCI 602 Safety and Performance 1 Year Post-Implantation in Adults and Children: A Multicentric Post-Market Study.

OBJECTIVE: To confirm the long-term safety and performance of the Bonebridge BCI 602 in patients suffering from conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) over a 12-month period post-implantation. STUDY DESIGN: Multicentric, multinational, ambidirectional, observational Post-Market Clinical Follow-Up (PMCF) study. SETTING: Eight tertiary referral hospitals. PARTICIPANTS: Fifty-two participants in 3 categories: adults CMHL (N=24), children CMHL (N=17), and SSD (N=11; 9 adults and 2 children). INTERVENTION: Participants were implanted with the Bonebridge BCI 602 device. MAIN OUTCOME MEASURES: Outcome measures focused on sound field thresholds (SF), word recognition scores (WRS), speech reception thresholds (SRT) in both quiet and noise, adverse events, and subjective satisfaction (SSQ and AQoL questionnaires) at initial activation and at 3-month and 12-month post-implantation. RESULTS: Safety was established by stable bone conduction (BC) thresholds and a low adverse event rate with no unanticipated events. Safety was underlined by clinically relevant improvements in the health-related assessment of Quality of Life (AQoL) questionnaire of mean+0.1 (adults and children CMHL) and +0.07 (SSD). Hearing significantly improved in sound field thresholds with mean functional gains of 24.05±8.68 dB (adults CMHL), 21.34±25.43 dB (children CMHL), and 32.89±25.87 dB (SSD). Mean word recognition scores improved by 65.83±28.62 percent points (PP) for adult CMHL and 65.77±27.53 PP for children CMHL and speech reception thresholds (SRT) in quiet by 15.4±9.34 dB and 19.96±14.66 dB, respectively. SRT in noise improved by -5.57±4.23 dB (adults; S 0° N 0° ), -5.12±5.08 dB (children, S 0° N 0° ), and -3.05±3.06 dB (SSD, S SSD N NH ). Subjective hearing ability tested with the Speech, Spatial, and Qualities (SSQ) of Hearing questionnaire improved and was clinically relevant for the adult (+2.23) and children (+1.51) CMHL groups. CONCLUSIONS: The Bonebridge BCI 602 demonstrates significant enhancements in hearing and speech understanding 12 months postoperatively, showing high user satisfaction and safety.