Lefebvre Philippe Pierre, Müller Joachim, Mark Gerhard, Schwarze Florian, Hochmair Ingeborg
Service ORL, Liège University, CHU de Liège, Avenue de l'hôpital 1, 4000, Liège, Belgium.
Klinikum der Universität München, Campus Großhadern, Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Marchioninistraße 12, 81377, München, Germany.
Commun Med (Lond). 2025 Jan 8;5(1):10. doi: 10.1038/s43856-024-00719-0.
Cochlear implants (CIs) are neuroprosthetic devices which restore hearing in severe-to-profound hearing loss through electrical stimulation of the auditory nerve. Current CIs use an externally worn audio processor. A long-term goal in the field has been to develop a device in which all components are contained within a single implant. Here, we present initial clinical results with the totally implantable cochlear implant (TICI). The primary objective of this study was to assess the safety of the device in adults who suffer from bilateral severe-to-profound sensorineural hearing loss.
This study used a design with non-randomized single group assignment (trial registration: NCT04571333). Six implantations took place beginning in September 2020. Data collection took place at the two participating CI centers. Adverse events (the primary outcome), speech perception, patient reported outcomes, and device usage statistics were collected over the subsequent 52 weeks. A within-subjects comparison was used in which each participant was evaluated both with the TICI and with an external SONNET audio processor.
One anticipated serious adverse device effect (ASADE) occurred. After treatment the event resolved without sequelae. No unanticipated serious adverse device effects (USADE) occurred. Speech perception in quiet and in noise scores were comparable between the TICI and the SONNET audio processor. Scores on the validated patient reported outcome instruments HUI3, SSQ-12, and HISQUI-19 all increased over the duration of the study. User satisfaction scores as reported in their daily diary also increased over the duration of the study. Based on device usage metrics, all but one user used the TICI without an external processor the majority of the time.
The primary outcome of assessing the safety of the device was achieved. The TICI provides high levels of hearing performance, comparable to those of a conventional CI. The development of the TICI expands the range of options for treatment of hearing loss.
人工耳蜗（CI）是一种神经假体装置，通过对听神经进行电刺激来恢复重度至极重度听力损失患者的听力。目前的人工耳蜗使用外部佩戴的音频处理器。该领域的一个长期目标是开发一种所有组件都包含在单个植入物中的装置。在此，我们展示了完全可植入人工耳蜗（TICI）的初步临床结果。本研究的主要目的是评估该装置在双侧重度至极重度感音神经性听力损失成人患者中的安全性。
本研究采用非随机单组分配设计（试验注册号：NCT04571333）。从2020年9月开始进行了6例植入手术。数据收集在两个参与的人工耳蜗中心进行。在随后的52周内收集不良事件（主要结局）、言语感知、患者报告结局和装置使用统计数据。采用受试者内比较，即对每位参与者同时使用TICI和外部SONNET音频处理器进行评估。
发生了1例预期的严重器械不良事件（ASADE）。治疗后该事件得以解决，无后遗症。未发生意外的严重器械不良事件（USADE）。TICI和SONNET音频处理器在安静和噪声环境下的言语感知得分相当。在经过验证的患者报告结局工具HUI3、SSQ - 12和HISQUI - 19上的得分在研究期间均有所提高。他们的日常日记中报告的用户满意度得分在研究期间也有所提高。根据装置使用指标，除1名用户外，大多数用户在大部分时间使用TICI时无需外部处理器。
实现了评估该装置安全性的主要结局。TICI提供了与传统人工耳蜗相当的高水平听力性能。TICI的开发扩大了听力损失治疗的选择范围。
