TY - JOUR
T1 - The Bonebridge BCI 602 Safety and Performance 1 Year Post-Implantation in Adults and Children
T2 - A Multicentric Post-Market Study
AU - Plontke, Stefan K
AU - Lenarz, Thomas
AU - Toner, Joseph
AU - Keintzel, Thomas
AU - Sprinzl, Georg
AU - Baumgartner, Wolf-Dieter
AU - Koitschev, Assen
AU - Schmutzhard, Joachim
AU - Götze, Gerrit
AU - Rahne, Torsten
AU - Knoelke, Nicole
AU - Busch, Susan
AU - Corkill, Stephanie
AU - Raffelsberger, Tobias
AU - Niederwanger, Lisa
AU - Magele, Astrid
AU - Schörg, Philipp
AU - Honeder, Clemens
AU - Liepins, Rudolfs
AU - Berger, Nadine
AU - Koci, Viktor
AU - Wiek, Robert
N1 - Publisher Copyright:
Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc on behalf of Otology & Neurotology, Inc.
PY - 2026/1/1
Y1 - 2026/1/1
N2 - 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; S0°N0°), -5.12±5.08 dB (children, S0°N0°), and -3.05±3.06 dB (SSD, SSSDNNH). 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.
AB - 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; S0°N0°), -5.12±5.08 dB (children, S0°N0°), and -3.05±3.06 dB (SSD, SSSDNNH). 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.
UR - https://www.scopus.com/pages/publications/105024736051
U2 - 10.1097/MAO.0000000000004688
DO - 10.1097/MAO.0000000000004688
M3 - Journal article
C2 - 41250191
SN - 1531-7129
VL - 47
SP - 175
EP - 184
JO - Otology and Neurotology
JF - Otology and Neurotology
IS - 1
ER -