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核研究平台8系统中更高刺激率的临床评估

Clinical evaluation of higher stimulation rates in the nucleus research platform 8 system.

作者信息

Plant Kerrie, Holden Laura, Skinner Margo, Arcaroli Jennifer, Whitford Lesley, Law Mary-Ann, Nel Esti

机构信息

Cooperative Research Centre for Cochlear Implant and Hearing Aid Innovation, Melbourne, Australia.

出版信息

Ear Hear. 2007 Jun;28(3):381-93. doi: 10.1097/AUD.0b013e31804793ac.

DOI:10.1097/AUD.0b013e31804793ac
PMID:17485987
Abstract

OBJECTIVE

The effect on speech perception of using higher stimulation rates than the 14.4 kHz available in the Nucleus 24 cochlear implant system was investigated. The study used the Nucleus Research Platform 8 (RP8) system, comprising the CI24RE receiver-stimulator with the Contour electrode array, the L34SP body-worn research speech processor, and the Nucleus Programming Environment (NPE) fitting and Neural Response Telemetry (NRT) software. This system enabled clinical investigation of higher stimulation rates before an implementation in the Freedom cochlear implant system commercially released by Cochlear Limited.

DESIGN

Use of higher stimulation rates in the ACE coding strategy was assessed in 15 adult subjects. An ABAB experimental design was used to control for order effects. Program A used a total stimulation rate of between 12 kHz and 14.4 kHz. This program was used for at least the first 3 mo after initial device activation. After evaluation with this program, each subject was provided with two different higher stimulation rate programs: one with a total stimulation rate of 24 kHz and the other with a total stimulation rate of 32 kHz. After a 6-week period of familiarization, each subject identified his/her preferred higher rate program (program B), and this was used for the evaluation. Subjects then repeated their use of program A for 3 wk, then program B for 3 wk, before the second evaluation with each. Speech perception was evaluated by using CNC open-set monosyllabic words presented in quiet and CUNY open-set sentences presented in noise. Preference for stimulation rate program was assessed via a subjective questionnaire. Threshold (T)- and Comfortable (C)-levels, as well as subjective reports of tinnitus, were monitored for each subject throughout the study to determine whether there were any changes that might be associated with the use of higher stimulation rates.

RESULTS

No significant mean differences in speech perception results were found for the group between the two programs for tests in either quiet or noise. Analysis of individual subject data showed that five subjects had significant benefit from use of program B for tests administered in quiet and for tests administered in noise. However, only two of these subjects showed benefit in both test conditions. One subject showed significant benefit from use of program A when tested in quiet, whereas another showed benefit with this program in noise. Each subject's preferred program varied. Five subjects reported a preference for program A, eight subjects reported a preference for program B and two reported no overall preference. Preference between the different stimulation rates provided within program B also varied, with 10 subjects preferring 24 kHz and five preferring 32 kHz total stimulation rates. A significant increase in T-levels from baseline measures was observed after three weeks of initial experience with program B, however there was no difference between the baseline levels and those obtained after five weeks of use. No significant change in C-levels was found over the monitoring period. No long-term changes in tinnitus that could be associated with the use of the higher stimulation rates were reported by any of the subjects.

CONCLUSIONS

The use of higher stimulation rates may provide benefit to some but not all cochlear implant recipients. It is important to optimize the stimulation rate for an individual to ensure maximal benefit. The absence of any changes in T- and C-levels or in tinnitus suggests that higher stimulation rates are safe for clinical use.

摘要

目的

研究使用高于 Nucleus 24 型人工耳蜗系统中可用的 14.4 kHz 的刺激速率对言语感知的影响。该研究使用了 Nucleus 研究平台 8(RP8)系统,其包括带有 Contour 电极阵列的 CI24RE 接收器 - 刺激器、L34SP 穿戴式研究言语处理器以及 Nucleus 编程环境(NPE)拟合和神经反应遥测(NRT)软件。该系统能够在科利耳有限公司商业发布的 Freedom 人工耳蜗系统中实施之前,对更高刺激速率进行临床研究。

设计

在 15 名成年受试者中评估了在 ACE 编码策略中使用更高刺激速率的情况。采用 ABAB 实验设计来控制顺序效应。程序 A 使用的总刺激速率在 12 kHz 至 14.4 kHz 之间。该程序在初始设备激活后的至少前 3 个月使用。在用该程序评估后,为每个受试者提供了两个不同的更高刺激速率程序:一个总刺激速率为 24 kHz,另一个总刺激速率为 32 kHz。经过 6 周的熟悉期后,每个受试者确定其偏好的更高速率程序(程序 B),并将其用于评估。然后受试者先重复使用程序 A 3 周,再使用程序 B 3 周,之后对每个程序进行第二次评估。通过使用在安静环境中呈现的 CNC 开放式单音节词和在噪声环境中呈现的纽约城市大学开放式句子来评估言语感知。通过主观问卷评估对刺激速率程序的偏好。在整个研究过程中,对每个受试者的阈值(T)和舒适(C)水平以及耳鸣的主观报告进行监测,以确定是否存在可能与使用更高刺激速率相关的任何变化。

结果

在安静或噪声环境下进行测试时,该组在两个程序之间的言语感知结果未发现显著的平均差异。对个体受试者数据的分析表明,有 5 名受试者在安静环境下和噪声环境下进行测试时,使用程序 B 有显著益处。然而,这些受试者中只有 2 名在两种测试条件下均显示有益处。一名受试者在安静环境下测试时使用程序 A 有显著益处,而另一名受试者在噪声环境下使用该程序有有益处。每个受试者的偏好程序各不相同。5 名受试者表示偏好程序 A,8 名受试者表示偏好程序 B,2 名受试者表示无总体偏好。程序 B 中提供的不同刺激速率之间的偏好也有所不同,10 名受试者更喜欢 24 kHz 的总刺激速率,5 名受试者更喜欢 32 kHz 的总刺激速率。在使用程序 B 初始体验三周后,观察到 T 水平相对于基线测量有显著增加,然而在使用五周后获得的基线水平与这些水平之间没有差异。在监测期内未发现 C 水平有显著变化。没有任何受试者报告与使用更高刺激速率相关的耳鸣长期变化。

结论

使用更高刺激速率可能对部分但并非所有人工耳蜗植入者有益。为个体优化刺激速率以确保最大益处很重要。T 水平和 C 水平以及耳鸣均未发生任何变化,这表明更高刺激速率在临床使用中是安全的。

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