Ear, Nose and Throat Department, University Clinic St. Poelten, Karl Landsteiner Private University, St. Poelten.
Ear, Nose and Throat Department, University Clinic Innsbruck, Innsbruck.
Otol Neurotol. 2021 Jul 1;42(6):858-866. doi: 10.1097/MAO.0000000000003159.
Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation.
Prospective, single-subject repeated-measures design.
Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶.
Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz.
Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI).
Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires.
Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study.
Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.
研究主动经皮骨导植入物在植入后长达 36 个月的成人和儿童中的长期安全性和性能。
前瞻性、单受试者、重复测量设计。
德国和奥地利的八家耳鼻喉科医院。*†‡§||¶#∗∗†† 以上列出的未参与研究的附属机构。‡‡§§||||¶¶。
57 名德语患者（49 名成人和 8 名儿童）患有传导性或混合性听力损失，在 500 至 3000 Hz 之间的频率上，上骨导阈值限制为 45 dB HL。
植入 Bonebridge 经皮骨导听力植入物（tBCI）。
患者术前和术后长达 36 个月的纯音平均听阈（PTA4）（0.5、1、2、4 kHz）阈值（气导、骨导和声场）和言语感知（词识别分数[WRS]和言语接受阈值[SRT50%]）。还对患者进行了不良事件监测和生活质量问卷评估。
言语感知（WRS：术前：17.60%，初始激活[IA]：74.23%，3M：83.65%，12M：83.46%，24M：84.23%，36M：84.42%；SRT50%：术前：65.56 dB SPL，IA：47.67 dB SPL，3M：42.61 dB SPL，12M：41.11 dB SPL，24M：41.74 dB SPL，36M：42.43 dB SPL）和声场阈值（术前：57.66 dB HL，IA：33.82 dB HL，3M：29.86 dB HL，12M：28.40 dB HL，24M：28.22 dB HL，36M：28.52 dB HL）在所有辅助术后访视中均显著改善。气导和骨导阈值无显著变化，证实了患者未受助听力的保留。所有不良事件均在研究结束时得到解决。
tBCI 在植入后 36 个月的儿童和成人中表现出安全性和性能。
