Abstract：
OBJECTIVE: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD).
METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements.
RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached.
CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient\'s anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.
METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements.
RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached.
CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient\'s anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.
摘要：
目的：这项欧洲多中心研究旨在证明BonebridgeBCI602在患有传导性听力损失（CHL）的儿童和成人中的安全性和性能，混合听力损失（MHL），或单侧感音神经性耳聋（SSD）。
方法：纳入三个研究组中的33例患者（13例成人和10例CHL或MHL儿童和10例SSD患者）。患者是他们自己的对照（单受试者重复测量），比较无辅助或术前与术后3个月的结局。通过声场阈值（SF）评估性能，安静(SRT)和噪声(SNR)中的单词识别得分(WRS)和/或语音接收阈值。通过特定于设备的手术问卷证明了安全性，不良事件报告和稳定的纯音测量。
结果：BonebridgeBCI602显著提高了SF阈值（+25.5dBCHL/MHL/SSD），WRS中的语音清晰度(+68.0%CHL/MHL)和安静中的SRT(-16.5dBC/MHL)和噪声中的SRT(-3.51dBSNRSSD)。空气传导(AC)和骨传导(BC)阈值随时间保持稳定。所有不良事件均得到解决，没有意想不到的。CHL/MHL组的平均音频处理器佩戴时间(小时[h]/天)为成人约13小时,儿科约11小时，SSD组约6小时。CHL/MHL组的平均手术时间为57分钟，SSD组为42分钟。BCI602的多功能性（减少钻孔深度和弯曲过渡以实现最佳放置的能力）允许正常治疗，手术前和畸形的解剖结构。达到所有听力学终点。
结论：BonebridgeBCI602显著改善了听阈和言语理解。由于植入物的放置遵循患者的解剖结构而不是设备的形状，并且手术的持续时间比其前身短，BCI602更容易植入。手术后3个月，成人和儿童以及CHL/MHL和SSD适应症的性能和安全性得到了证明。
方法：纳入三个研究组中的33例患者（13例成人和10例CHL或MHL儿童和10例SSD患者）。患者是他们自己的对照（单受试者重复测量），比较无辅助或术前与术后3个月的结局。通过声场阈值（SF）评估性能，安静(SRT)和噪声(SNR)中的单词识别得分(WRS)和/或语音接收阈值。通过特定于设备的手术问卷证明了安全性，不良事件报告和稳定的纯音测量。
结果：BonebridgeBCI602显著提高了SF阈值（+25.5dBCHL/MHL/SSD），WRS中的语音清晰度(+68.0%CHL/MHL)和安静中的SRT(-16.5dBC/MHL)和噪声中的SRT(-3.51dBSNRSSD)。空气传导(AC)和骨传导(BC)阈值随时间保持稳定。所有不良事件均得到解决，没有意想不到的。CHL/MHL组的平均音频处理器佩戴时间(小时[h]/天)为成人约13小时,儿科约11小时，SSD组约6小时。CHL/MHL组的平均手术时间为57分钟，SSD组为42分钟。BCI602的多功能性（减少钻孔深度和弯曲过渡以实现最佳放置的能力）允许正常治疗，手术前和畸形的解剖结构。达到所有听力学终点。
结论：BonebridgeBCI602显著改善了听阈和言语理解。由于植入物的放置遵循患者的解剖结构而不是设备的形状，并且手术的持续时间比其前身短，BCI602更容易植入。手术后3个月，成人和儿童以及CHL/MHL和SSD适应症的性能和安全性得到了证明。
