Department of Otorhinolaryngology, Head and Neck Surgery, Aalborg University Hospital, Aalborg, Denmark.
Department of Otorhinolaryngology, Head and Neck Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Otol Neurotol. 2024 Jun 1;45(5):556-563. doi: 10.1097/MAO.0000000000004190. Epub 2024 May 1.
To investigate the feasibility of early sound processor loading with two separate bone-anchored hearing aid implants 1 to 2 weeks after implantation. Secondary endpoints included registration of any postoperative complications, skin reactions, and any adverse events.
Prospective, nonrandomized, noncontrolled, multicenter clinical trial.
Tertiary referral center.
Sixty adult patients, eligible for bone-anchored hearing aid surgery, were enrolled.
Implantation of the bone-anchored hearing aid implants were done using minimally invasive surgery with tissue preservation.
Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Follow-ups were scheduled 5 to 12 days, 4 to 8 weeks, 6 months, and 12 months postoperatively. Differences between the lowest ISQ values (ISQ low) over time were analyzed by paired-samples t test with a significance level of 0.05. Skin and soft tissue reactions were assessed according to Holger's classification.
Loading time of the Ponto Wide implant was 11.6 ± 1.4 days (SD) in average (median, 12 d; range, 7-19 d). Loading of the Ponto BHX implant was done 9.7 ± 3.5 days (SD) postoperatively (median, 9 d; range, 5-19 d). The implant stability increased significantly during the 12-month study period with both implants. One Ponto BHX implant was lost. Skin and soft tissue reactions were few in both groups. Across all planned follow-up visits, no skin and soft tissue reactions were observed in 86% (Ponto BHX implant) and 85% (Ponto Wide implant).
Very early loading of sound processors after percutaneous bone-anchored hearing system surgery is safe already 1 to 2 weeks postoperatively.
研究在骨锚定式助听器植入术后 1 至 2 周内对两个独立的骨锚定式听力植入物进行早期处理器加载的可行性。次要终点包括记录任何术后并发症、皮肤反应和任何不良事件。
前瞻性、非随机、非对照、多中心临床试验。
三级转诊中心。
纳入 60 名成年患者，适合进行骨锚定式助听器手术。
使用微创保留组织技术植入骨锚定式听力植入物。
使用共振频率分析记录植入体稳定性商数（ISQ）值。随访时间分别为术后 5 至 12 天、4 至 8 周、6 个月和 12 个月。采用配对样本 t 检验分析随时间变化的最低 ISQ 值（ISQ low）之间的差异，显著性水平为 0.05。根据 Holger 分类评估皮肤和软组织反应。
Ponto Wide 植入物的加载时间平均为 11.6 ± 1.4 天（标准差）（中位数，12 d；范围，7-19 d）。Ponto BHX 植入物的加载时间为术后 9.7 ± 3.5 天（标准差）（中位数，9 d；范围，5-19 d）。在 12 个月的研究期间，两种植入物的植入体稳定性均显著增加。一个 Ponto BHX 植入物丢失。两组皮肤和软组织反应均较少。在所有计划的随访中，86%（Ponto BHX 植入物）和 85%（Ponto Wide 植入物）的患者未观察到皮肤和软组织反应。
在经皮骨锚定式听力系统手术后 1 至 2 周内，对声音处理器进行非常早期的加载已经是安全的。
