Hals-Nasen-Ohren-Abteilung, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften und Karl-Landsteiner Institut für Implantierbare Hörsysteme, Universitätsklinikum St. Pölten, Dunant-Platz 1, 3100, St. Pölten, Austria.
Regional Auditory Implant Centre, Beech Hall Centre, Belfast, Northern Ireland, UK.
Eur Arch Otorhinolaryngol. 2023 Apr;280(4):1565-1579. doi: 10.1007/s00405-022-07792-y. Epub 2023 Jan 10.
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).
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.
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.
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.
这项欧洲多中心研究旨在证明 Bonebridge BCI 602 在患有传导性听力损失（CHL）、混合性听力损失（MHL）或单侧感音神经性聋（SSD）的儿童和成人中的安全性和性能。
33 名患者（13 名成人和 10 名患有 CHL 或 MHL 的儿童和 10 名 SSD 患者）被纳入三个研究组。患者为自身对照（单例重复测量），比较未佩戴或术前与术后 3 个月的结果。通过声场阈值（SF）、言语识别评分（WRS）和/或安静时的言语接受阈（SRT）和噪声中的言语接受阈（SNR）来评估性能。通过特定于设备的手术问卷、不良事件报告和纯音测量来证明安全性。
Bonebridge BCI 602 显著改善了 SF 阈值（+25.5dB CHL/MHL/SSD）、言语可懂度（WRS 中+68.0% CHL/MHL）和安静时的 SRT（-16.5dB C/MHL）和噪声中的 SRT（-3.51dB SNR SSD）。空气传导（AC）和骨传导（BC）阈值随时间保持稳定。所有不良事件均已解决，无意外事件。CHL/MHL 组成人平均每天佩戴音频处理器时间约为 13 小时，儿童约为 11 小时，SSD 组约为 6 小时。CHL/MHL 组的平均手术时间为 57 分钟，SSD 组为 42 分钟。BCI 602 的多功能性（减少钻孔深度和能够弯曲过渡以实现最佳放置）允许治疗正常、术前和畸形解剖结构。所有听力学终点均达到。
Bonebridge BCI 602 显著改善了听力阈值和言语理解。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，并且手术时间比其前身更短，因此 BCI 602 更容易植入。术后 3 个月，成人和儿童以及 CHL/MHL 和 SSD 适应证均证明了性能和安全性。
