Goethe-University Frankfurt, ENT-Department/Audiological Acoustics, Frankfurt a. M, Germany,
Goethe-University Frankfurt, ENT-Department/Audiological Acoustics, Frankfurt a. M, Germany.
Audiol Neurootol. 2021;26(5):327-337. doi: 10.1159/000512760. Epub 2021 Mar 3.
The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3-6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery.
Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4-6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study.
In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery.
The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups.
Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.
人工耳蜗（CI）是治疗重度至极重度听力损失患者的标准程序。过去，CI 手术后通常需要 3-6 周的标准愈合期，然后才能首次激活声音处理器。手术技术和器械的进步使得在手术后 14 天内可以更早地首次激活处理器。
评估手术后 14 天内对 CI 设备的早期激活，与手术后 4-6 周首次激活进行比较，并评估在 12 个月观察期内早期拟合的可行性和安全性，是本研究的目的。
在一项前瞻性研究中，将 127 名计划接受 CI 手术的患者分为早期拟合组（EF，n=67）和对照组（CG，n=60）。使用个人问卷评估 EF 的医疗和技术结果。在 CI 手术后的第一年，比较 EF 和 CG 的医疗副作用、言语识别和随访工作。
EF 患者中有 97%能够进行早期拟合。在 EF 中，处理器的激活时间比 CG 早 25 天。两组均未观察到重大并发症。在随访预约时，两组的副作用，如疼痛和平衡问题，发生频率相当。在初始拟合时，EF 显示出更高的医疗小并发症发生率（p<0.05）。在第一年使用 CI 发展言语识别时，没有观察到差异。此外，两组在 CI 手术后第一年的随访工作相当。
早期拟合声音处理器是一种可行且安全的程序，随访工作量相当。尽管 EF 中观察到更多的早期小并发症，但早期拟合不会导致长期伤口愈合问题。建议作为 CI 随访的一部分，定期检查磁铁强度，因为术后必须预期伤口肿胀。早期拟合程序使 CI 手术和首次声音处理器激活之间的等待时间明显缩短。
