儿童患者中新型主动骨传导装置的首次应用经验
First Experience With a New Active Bone Conduction Device in Pediatric Patients.
文献信息
| PMID | 42956385 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Nils Prenzler |
| 作者单位 | Department of Otorhinolaryngology and Cluster of Excellence "Hearing4all.connects", Hannover Medical School, Hannover, Germany. |
| 期刊 | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology |
| SCI 分区 | Q2 |
| IF | 1.9 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 本回顾性分析旨在评估新型主动经皮骨传导植入体Sentio在儿童患者中的可行性、手术安全性及早期听力学获益。
设计： 回顾性病例系列。
研究样本： 7名儿童（8耳），年龄3.6至9.7岁，于2024年12月至2025年3月期间因先天性耳道闭锁（6耳）或耳蜗神经发育不全导致的单侧耳聋（2耳）接受Sentio系统植入。
结果： 所有手术均使用Sentio Ti植入体成功完成。在骨床准备过程中出现了对硬脑膜、乙状窦和/或乳突气房的有限暴露，但无撕裂、出血、脑脊液漏、压迫或临床后遗症。截至首次调机，未发生围手术期或术后不良事件。术后骨导阈值保持稳定，证实耳蜗储备得以保留。Sentio辅助下的自由场平均阈值在0.5、1、2和4 kHz分别为22.5、20.0、18.6和18.6 dB HL。首次调机时，所有患者在65 dB SPL的会话声级下言语识别率平均为96.3%（范围：85-100%）。相对平坦的换能器和柔性带固定便于在颅骨较薄的幼儿中安全植入。
结论： Sentio Ti植入在该选定队列中技术可行，截至首次调机无临床不良事件，且早期辅助效果良好。需要更大规模的前瞻性研究，采用标准化测试和更长随访，以评估长期安全性、颅骨生长、植入体稳定性、MRI相关限制及持续获益。
英文摘要
OBJECTIVE: The aim of this retrospective analysis was to evaluate the feasibility, surgical safety, and early audiological benefit of the new active transcutaneous bone conduction implant Sentio in pediatric patients.
DESIGN: Retrospective case series.
STUDY SAMPLE: Seven children (8 ears), aged 3.6 to 9.7 years, underwent implantation of a Sentio system between December 2024 and March 2025 for congenital aural atresia (6 ears) or single-sided deafness due to cochlear nerve aplasia (2 ears).
RESULTS: All surgeries were completed successfully using the Sentio Ti Implant. Limited exposure of the dura, sigmoid sinus, and/or mastoid air cells occurred during bone-bed preparation, but there was no laceration, bleeding, cerebrospinal fluid leak, compression, or clinical sequela. No perioperative or postoperative adverse events occurred through initial fitting. Bone conduction thresholds remained stable postoperatively, confirming preservation of cochlear reserve. Mean Sentio-aided free-field thresholds were 22.5, 20.0, 18.6, and 18.6 dB HL at 0.5, 1, 2, and 4 kHz, respectively. Word recognition scores at initial fitting averaged 96.3% in all patients (range: 85-100%) at a conversational level of 65 dB SPL. The relatively flat transducer and flexible band fixation facilitated safe implantation in young children with thin cranial bone.
CONCLUSION: Sentio Ti implantation was technically feasible in this selected cohort, with no clinical adverse events through initial fitting and favorable early aided outcomes. Larger prospective studies with standardized testing and longer follow-up are required to assess long-term safety, skull growth, implant stability, MRI-related limitations, and sustained benefit.