ENT Department, Rehabilitation Hospital, University of Medicine and Pharmacy "Gr. T. Popa", 14, Pantelimon Halipa Street, 700661 Iasi, Romania.
Eur Arch Otorhinolaryngol. 2013 Mar;270(4):1507-12. doi: 10.1007/s00405-012-2266-2. Epub 2012 Nov 18.
Over the past decade, the adoption of universal hearing screening in newborns has led to earlier detection of hearing problems and significant lowering of the age of first cochlear implantation. As a consequence, recipients are now expected to keep their cochlear implants (CIs) for a longer period of time. Comprehensive longitudinal information on CI reliability is essential for device choice. The aim of this study was to assess the reliability (in children and adults) of the latest generation of the Digisonic(®) SP CI launched in 2006 by Neurelec. Failure rate (FR) and cumulative survival rate (CSR) for a 5-year period were calculated. This survey is a multicenter retrospective study. A questionnaire was sent to nine CI centers requesting information about patients implanted with Neurelec Digisonic(®) SP CIs. FR and CSR over a 5-year period were calculated on this group. Collaborating centers collected data on 672 patients (362 children and 310 adults) implanted between March 2006 and March 2011. The overall rate of explantation was 2.23 % (15 cases): six devices were explanted due to device failure (0.89 %) and nine were explanted for medical reasons (1.34 %). Four patients were lost to follow-up. The CSR at 5 years was 98.51 % on all patients, 98.48 % for children and 98.57 % for adults. FR was 0.97 % for adults and 0.83 % for children. This first independent study that assesses FR and CSR on the current generation of Digisonic(®) SP CI represents an important resource that can help clinicians and patients during their device choice.
在过去的十年中,新生儿普遍接受听力筛查,这导致听力问题的早期发现,并显著降低了首次人工耳蜗植入的年龄。因此,现在接受者预计将更长时间地使用他们的人工耳蜗(CI)。CI 可靠性的综合纵向信息对于设备选择至关重要。本研究的目的是评估 2006 年由 Neurelec 推出的最新一代 Digisonic(®) SP CI 在儿童和成人中的可靠性。计算了 5 年期间的故障率(FR)和累积存活率(CSR)。这项调查是一项多中心回顾性研究。向 9 个 CI 中心发送了一份问卷,要求提供植入 Neurelec Digisonic(®) SP CI 的患者信息。根据该组数据计算了 5 年内的 FR 和 CSR。合作中心收集了 672 名患者(362 名儿童和 310 名成人)的数据,这些患者于 2006 年 3 月至 2011 年 3 月之间植入。总体取出率为 2.23%(15 例):六台设备因设备故障(0.89%)和九台设备因医疗原因(1.34%)而被取出。四名患者失访。所有患者的 CSR 在 5 年内为 98.51%,儿童为 98.48%,成人为 98.57%。FR 为成人 0.97%,儿童 0.83%。这是第一项评估当前一代 Digisonic(®) SP CI 的 FR 和 CSR 的独立研究,它为临床医生和患者在选择设备时提供了重要的资源。