Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Otol Neurotol. 2013 Jan;34(1):104-10. doi: 10.1097/MAO.0b013e318277a282.
To clinically evaluate the performance of a titanium percutaneous bone-anchored hearing implant (BAHI) using a 3-week healing period. Short-term implant survival, stability changes, and skin reactions are evaluated from the initial implantation to 6 months postimplantation.
Thirty patients eligible for a BAHI were included in an open, prospective clinical investigation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis (RFA) at the time of implantation and at 10 days; at 3, 6, and 12 weeks; and at 6 months after placement of the implant. Sound processor fitting was performed 3 weeks after implantation. Skin reactions were evaluated according to the Holgers classification.
One implant was lost 3 days after implantation because of poor bone quality. No implant loss occurred in the remaining 29 patients (96.7%). The mean ISQ value at the time of implantation was 67.1 (range, 44-71). Compared with baseline, there was a significant dip of -2.2 ISQ units at 10 days (mean, 65.7; p = 0.0093). There was a positive change in mean ISQ compared with baseline over the subsequent visits. No reduction in mean ISQ values was observed after implant loading. Skin reactions were observed incidentally (mean over all visits, 9.7%) and were generally mild (Holgers Grade 1; mean 9.0%). An adverse skin reaction (Holgers Grade 2) was observed only once (mean, 0.7%).
The current study suggests that loading the implant and 6-mm abutment with the sound processor at 3 weeks is safe. The stability of the implant as measured by ISQ values had reached its baseline value within 3 weeks after implantation. The degree of stability was not affected by implant loading. Only mild skin reactions were observed incidentally. This study supports the use of early loading at 3 weeks as current practice in healthy adults with good bone quality; thus, these adults can benefit from the rehabilitation of their hearing at an earlier stage.
通过 3 周的愈合期，对钛经皮骨锚定式听力植入物（BAHI）的临床性能进行评估。从植入初始到植入后 6 个月，评估短期植入物存活率、稳定性变化和皮肤反应。
30 名符合 BAHI 植入条件的患者纳入一项开放性、前瞻性临床研究。植入时和植入后 10 天、3、6 和 12 周以及植入后 6 个月，使用共振频率分析（RFA）记录植入稳定性商（ISQ）值。植入后 3 周进行声音处理器适配。根据 Holgers 分类评估皮肤反应。
1 例患者因骨质量差，植入后 3 天失植。其余 29 例患者（96.7%）未发生植入物丢失。植入时平均 ISQ 值为 67.1（范围，44-71）。与基线相比，植入后 10 天 ISQ 值显著下降-2.2 个单位（平均 65.7；p = 0.0093）。与基线相比，随后各次就诊时 ISQ 值呈正变化。植入物负载后，平均 ISQ 值无下降。皮肤反应偶然发生（所有就诊的平均值为 9.7%），通常为轻度（Holgers 1 级；平均 9.0%）。仅观察到 1 例（平均 0.7%）不良皮肤反应（Holgers 2 级）。
本研究表明，在 3 周时用声音处理器加载植入物和 6mm 接杆是安全的。植入物的稳定性（以 ISQ 值衡量）在植入后 3 周内已恢复至基线值。植入物的稳定性不受负载的影响。仅偶然观察到轻度皮肤反应。该研究支持在健康、骨质量良好的成年人中采用 3 周早期负载的方法，因此这些成年人可以更早地受益于听力康复。
