Hearing, Speech, and Language Center, Sheba Medical Center, Ramat Gan, Israel.
Department of Communication Disorders, Faculty of Medical and Health Sciences, Steyer School of Health Professions, Tel Aviv University, Tel Aviv, Israel.
Otolaryngol Head Neck Surg. 2024 Oct;171(4):1140-1147. doi: 10.1002/ohn.805. Epub 2024 May 8.
Describe the clinical profile of revision cochlear implantation (RCI) cases involving device manufacturer conversion (RCI), compare them to cases without manufacturer conversion (RCI), and classify the reasons for manufacturer conversion (MC).
Retrospective case review.
Tertiary academic center.
Data on demographics, RCI indications, medical background, surgical details, and the reasons for MC were collected for all RCIs from 1989 to 2020. Post-RCI speech perception performance was categorized as unchanged, improved, or declined, according to clinically based criteria.
Of 185 RCIs, 39 (21%) involved MC, mostly in pediatric patients (67%). The leading RCI indications were device-related (59%) and medical (31%) failures. Initial implant manufacturers were Advanced Bionics (49%), Cochlear (25.5%), or Medel (25.5%). Most MC reasons were patient-driven (64%) versus CI team recommendations (36%). The RCI group demonstrated a 3-fold higher rate of medical indications than RCI (31% vs 11.5%, P = .007). The time interval from symptom onset to RCI was longer in RCI (43 vs 20.3 months, P = .001), and the rate of multiple revisions in the same ear was higher (25.6% vs 8.2%, P = .009). Complete reinsertion rates were high in both RCI and RCI (94.8% vs 94.5%, P = 1) without any complications. Speech perception improved or remained unchanged in most (84%) cases, with no significant difference between the groups (P = .183).
This retrospective study showed that RCI involving MC is safe and beneficial. Although RCI patients exhibited distinct clinical characteristics, MC did not impact surgical or speech perception outcomes. This provides evidence-based data to support informed decision-making by CI teams and patients.
描述涉及设备制造商转换（RCI）的修正耳蜗植入（RCI）病例的临床特征，将其与未进行制造商转换（RCI）的病例进行比较，并对制造商转换（MC）的原因进行分类。
回顾性病例研究。
三级学术中心。
收集了 1989 年至 2020 年所有 RCI 的人口统计学数据、RCI 适应证、医学背景、手术细节以及 MC 原因的数据。根据基于临床的标准，将 RCI 后的言语感知性能分为不变、改善或下降。
在 185 例 RCI 中，有 39 例（21%）涉及 MC，主要发生在儿科患者（67%）。主要的 RCI 适应证是设备相关（59%）和医学（31%）失败。初始植入制造商为 Advanced Bionics（49%）、Cochlear（25.5%）或 Medel（25.5%）。大多数 MC 原因是患者驱动（64%）而非 CI 团队建议（36%）。RCI 组的医学适应证发生率是 RCI 的 3 倍（31% vs 11.5%，P = .007）。RCI 组从症状出现到 RCI 的时间间隔更长（43 个月 vs 20.3 个月，P = .001），同一耳多次手术的发生率更高（25.6% vs 8.2%，P = .009）。RCI 和 RCI 组的完全重新插入率均较高（94.8% vs 94.5%，P = 1），且无任何并发症。大多数（84%）病例的言语感知能力改善或保持不变，两组之间无显著差异（P = .183）。
这项回顾性研究表明，涉及 MC 的 RCI 是安全且有益的。尽管 RCI 患者表现出明显的临床特征，但 MC 并未影响手术或言语感知结果。这为 CI 团队和患者提供了决策支持的循证数据。
