Garcia-Ibanez Luis, Macias Angel Ramos, Morera Constantino, Rodriguez Manuel Manrique, Szyfter Witold, Skarszynski Henryk, Emamdjomeh Hessam, Baumgartner Wolf-Dieter
Instituto de Otologia Garcia Ibanez, Barcelona, Spain.
Acta Otolaryngol. 2009 Jun;129(6):651-64. doi: 10.1080/00016480802369278.
Our study results confirm that it is possible to preserve preoperative hearing levels in the majority of subjects when using the Nucleus 24 Contour Advance provided that there is adherence to the major principles of 'soft surgery'. Our study group demonstrated that 71-86% of subjects showed preservation of preoperative hearing thresholds at 6 months to varying degree.
The aim of the study was to assess the degree of residual hearing preserved postoperatively in a group of standard cochlear implant (CI) candidates following implantation via soft surgery with a Nucleus 24 Contour Advance CI. Surgical technique variations from the soft surgery guidelines provided were assessed and their potential impact upon the conservation of residual hearing was examined.
A prospective multicentre study involving a within-subject repeated measures design with each subject acting as their own control was performed. Pure-tone audiometric thresholds were assessed and compared in both implanted and contralateral ears for each subject preoperatively as baseline measures and at 6 months postoperatively. Surgeons were asked to complete a questionnaire to capture various aspects of the surgical technique used for each subject. Variations in the surgical technique performed were examined for potential correlation with conservation of residual hearing. Twenty-eight adult subjects, with a severe to profound hearing impairment, were enrolled in the study across eight implant clinics in four countries.
In all, 36% of subjects demonstrated preservation of thresholds to within 10 dB of preoperative thresholds across the frequency range (0.25, 0.5, 1.0, 2.0 and 4.0 KHz) and for the low frequency range (0.25-1.0 KHz). Approximately two-thirds of subjects demonstrated preservation of preoperative thresholds to within 20 dB. Preservation of low frequency thresholds post-implant was shown to correlate moderately with cochleostomy site, being more likely for subjects with a site anterior-inferior to the round window but also possible with inferior locations; weakly with cochleostomy size, being more likely when smaller than 1.2 mm; and also with the use of Healon as a sealant and lubricant. Preservation of hearing thresholds across up to 4000 Hz was shown to correlate weakly with the use of suction following opening of the endostium and with bone dust contamination, both having a negative effect upon preservation, while no correlation was observed with the preservation of thresholds for low frequencies alone.
我们的研究结果证实,使用Nucleus 24 Contour Advance时,只要遵循“软手术”的主要原则,大多数受试者术前听力水平是可以保留的。我们的研究组表明,71%至86%的受试者在6个月时不同程度地保留了术前听力阈值。
本研究旨在评估一组标准人工耳蜗(CI)候选者在通过使用Nucleus 24 Contour Advance CI进行软手术植入后保留的残余听力程度。评估了与所提供的软手术指南不同的手术技术变化,并研究了它们对残余听力保留的潜在影响。
进行了一项前瞻性多中心研究,采用受试者自身对照的受试者内重复测量设计。在术前作为基线测量以及术后6个月时,对每个受试者的植入耳和对侧耳进行纯音听力阈值评估和比较。要求外科医生填写一份问卷,以获取每个受试者所使用手术技术的各个方面。检查所执行的手术技术变化与残余听力保留之间的潜在相关性。来自四个国家八个植入诊所的28名重度至极重度听力障碍的成年受试者参与了该研究。
总体而言,36%的受试者在整个频率范围(0.25、0.5、1.0、2.0和4.0千赫兹)以及低频范围(0.25 - 1.0千赫兹)内显示阈值保留在术前阈值的10分贝以内。大约三分之二的受试者显示术前阈值保留在20分贝以内。植入后低频阈值的保留与蜗窗造口部位呈中度相关,蜗窗造口部位位于圆窗前下方的受试者更有可能保留,蜗窗造口部位位于下方时也有可能;与蜗窗造口大小呈弱相关,蜗窗造口小于1.2毫米时更有可能保留;还与使用透明质酸钠作为密封剂和润滑剂有关。高达4000赫兹的听力阈值保留与打开内耳膜后使用吸引器以及骨粉污染呈弱相关,二者均对保留产生负面影响,而单独低频阈值的保留未观察到相关性。