跳至主要内容
临床试验/NCT02727842
NCT02727842已完成不适用

Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users

Cochlear5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Cochlear
入组人数
30
试验地点
5
主要终点
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire

研究概览

简要总结

Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

详细描述

One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
  • Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff
  • At least 3 months experience with the CP810,CP920 or CP910 sound processor
  • Ability to use 2 zinc air batteries with their current program (MAP)
  • Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

排除标准

  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
  • Additional disabilities that would prevent participation in evaluations
  • Implant types not currently supported by the CP950 sound processor (i.e.,N22)

结局指标

主要结局

Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire

时间窗: 1 month

To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: 1. Patient Reported Hearing Performance 2. Retention \& Comfort 3. Ease of use 4. Use of remote controls 5. Look \& feel 6. Reliability 7. Maintenance \& use

次要结局

未报告次要终点

研究者

发起方
Cochlear
申办方类型
Industry
责任方
Sponsor

研究点 (5)

Loading locations...

相似试验