Acceptance of the CP950 Sound Processor With Experienced CP810/CP910/CP920 BTE Sound Processor Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 23
- 主要终点
- Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
研究概览
简要总结
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years of age or older
- •At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
- •At least 3 months experience with the CP810,CP920 or CP910 sound processor
- •Native speaker in the language used to assess speech perception performance
- •Willingness to participate in and to comply with all requirements of the protocol
- •Able to score 30% or more at +15 SNR with CI alone
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
- •Nucleus 22 Implant
结局指标
主要结局
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
时间窗: 14 days
Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better.
次要结局
- Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor(In booth testing 1 day)
- Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .(in booth testing 1 day.)