宽直径骨锚式听力植入物的长期临床性能：超过10年的随访。
Long-Term Clinical Performance of a Wide-Diameter Bone-Anchored Hearing Implant: Over 10 Years of Follow-up.
文献信息
| PMID | 42727587 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Carine Hajema |
| 作者单位 | Department of Otorhinolaryngology and Head and Neck Surgery, Research School of Behavioural and Cognitive Neurosciences, Graduate School of Medical Sciences, University Medical Center Groningen, Groningen, The Netherlands. |
| 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： 探讨宽直径骨锚式听力植入物在植入后至少10年的长期存活率和稳定性、软组织反应以及生活质量。
研究设计： 本研究是先前已发表单中心试验的延续，这些试验具有6个月、3年和5年结果，并增加了植入后至少10年的一次随访。
患者和主要结局指标： 纳入来自先前试验63名参与者中的48名患者（49枚植入物），所有参与者均接受了Ponto Wide植入物。对所有63名患者（65枚植入物）评估了植入物存活率。大多数患者到门诊就诊，在那里测量植入物稳定性，并使用Holgers分类和IPS量表评估基台周围的软组织反应。此外，使用助听器国际结局量表（IOI-HA）和格拉斯哥获益量表（GBI）问卷评估生活质量。
结果： 包括取出植入物在内，10年植入物存活率为95.4%。在≥10年随访时，ISQ值高于手术基线，并且仅在3名患者中观察到轻微皮肤反应。未发生不良皮肤反应。与干预前相比，92.1%的患者（GBI）听力相关生活质量改善，IOI-HA评分中位数为4.3（IQR：3.7-4.6），表明满意度较高。
结论： Ponto Wide植入物显示出优异的长期结局，包括高植入物存活率、持续稳定性、极低的软组织并发症以及高患者报告满意度。这些结果证实，这种宽植入物的早期优势随时间持续存在。
英文摘要
OBJECTIVE: To investigate long-term survival and stability of a wide-diameter bone-anchored hearing implant, soft tissue reactions, and quality of life at least 10 years after implantation.
STUDY DESIGN: This study is a continuation of previously published single-center trials with 6-month, 3-year, and 5-year results, adding one follow-up visit at least 10 years postimplantation.
PATIENTS AND MAIN OUTCOME MEASURES: A total of 48 patients (49 implants) from 63 participants in previous trials, all of whom received the Ponto Wide implant, were included. Implant survival was evaluated for all 63 patients (65 implants). Most patients attended the outpatient clinic, where implant stability was measured and soft tissue reactions around the abutment were assessed using the Holgers classification and IPS scale. In addition, quality of life was evaluated using the International Outcome Inventory for Hearing Aids (IOI-HA) and the Glasgow Benefit Inventory (GBI) questionnaires.
RESULTS: The 10-year implant survival rate was 95.4%, including explantations. At the ≥10-year follow-up visit, ISQ values were higher compared to baseline at surgery, and minor skin reactions were observed in only 3 patients. No adverse skin reactions occurred. Hearing-related quality of life improved in 92.1% of patients (GBI) compared to before the intervention, and the median IOI-HA score was 4.3 (IQR: 3.7-4.6), indicating a high level of satisfaction.
CONCLUSION: The Ponto Wide implant shows excellent long-term outcomes with high implant survival, sustained stability, very low soft tissue complications, and high patient-reported satisfaction. These results confirm that the early advantages of this wide implant persist over time.