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临床试验/NCT03288753
NCT03288753已完成不适用

Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors

Oticon Medical18 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
18
主要终点
Satisfaction questionnaire

研究概览

简要总结

The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.

详细描述

Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries...). Some improvements available on the Neuro 2 may be particularly interesting for children.

The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.

The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • informed consent
  • Native French speaker or fluent French speaker
  • Patient already fitted with one or two speech processor Neuro 1 for at least 5 months

排除标准

  • vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
  • No Social security affiliation
  • non-compliant patient

结局指标

主要结局

Satisfaction questionnaire

时间窗: 15 minutes

The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.

次要结局

  • Speech comprehension in quiet(15 mins)
  • Speech comprehension in Noise(15 mins)
  • French Quick Sin(5 mins)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (18)

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