Otolaryngology Department, Dijon University Hospital, Dijon, France.
Entendre Hearing Aid Center, Dijon, France.
Audiol Neurootol. 2021;26(5):310-316. doi: 10.1159/000512496. Epub 2021 Mar 4.
Bonebridge® is a novel active bone-anchored hearing implant. The purpose of this study was to evaluate the ease of implantation, the hearing performances, and the patient-reported benefit.
This is a prospective cross-sectional study of 24 consecutive adult patients implanted for a mixed hearing loss (13 chronic otitis media (COM) and 11 other aetiologies). Twenty-one implants were placed in the retrosigmoid position and 3 in the mastoid. Audiometry, Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, as well as 5 implant-specific questions (analogue visual scale [AVS] 0-10 score), was administered.
Surgery lasted 73 ± 29.7 min on average. No major complication occurred. All patients were users at the last follow-up visit (median: 9-month range: 3-25). The average prosthetic gain was similar in COM and other aetiologies (43 ± 4.8 dB and 50 ± 7.2, respectively, not significant, Wilcoxon test). Bone-conduction thresholds were not deteriorated by surgery (Kruskal-Wallis test, not significant). APHAB scores improved in all categories except aversiveness (global score 45 ± 7.0% in COM and 32 ± 10.2% in others, not significant, and Wilcoxon test). Local pain (AVS: 3.23 ± 3.2, n = 16) and manipulation difficulties (3.1 ± 3.69) were low. The device was considered aesthetic (8.3 ± 2.49). Perfectible autonomy (5.0 ± 2.8) and difficulties wearing the implant during sport or at work (5.1 ± 3.47) were the weakest points.
BoneBridge® implant provides reproducible results for the rehabilitation of mixed hearing losses and unilateral hearing loss.
BoneBridge® 是一种新型的主动骨锚式听力植入物。本研究旨在评估植入的简易程度、听力表现和患者报告的获益。
这是一项前瞻性的连续 24 例成年患者的混合性听力损失(13 例慢性中耳炎(COM)和 11 例其他病因)的横断面研究。21 个植入物放置在后乙状窦位置,3 个植入物放置在乳突。进行听力测试、听力辅助获益简明问卷(APHAB)以及 5 个植入物特定问题(模拟视觉量表 [AVS] 0-10 评分)。
手术平均持续 73 ± 29.7 分钟。无重大并发症发生。所有患者在最后一次随访时均为使用者(中位数:9 个月范围:3-25)。COM 和其他病因的平均假体增益相似(分别为 43 ± 4.8dB 和 50 ± 7.2dB,无显著差异,Wilcoxon 检验)。骨导阈值不因手术而恶化(Kruskal-Wallis 检验,无显著差异)。APHAB 评分在除厌恶度外的所有类别均改善(COM 的总体评分 45 ± 7.0%和其他病因的 32 ± 10.2%,无显著差异,Wilcoxon 检验)。局部疼痛(AVS:3.23 ± 3.2,n = 16)和操作困难(3.1 ± 3.69)较低。该设备被认为具有美感(8.3 ± 2.49)。可完善的自主性(5.0 ± 2.8)和在运动或工作时佩戴植入物的困难(5.1 ± 3.47)是最薄弱的环节。
BoneBridge® 植入物可为混合性听力损失和单侧听力损失的康复提供可重复的结果。