A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
研究概览
简要总结
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'.
详细描述
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older.
- •Post lingually deafened.
- •Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422).
- •At least 6 months experience with a cochlear implant.
- •At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor
- •Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
- •Willingness to participate in and to comply with all requirements of the protocol.
- •Fluent speaker in English as determined by the investigator
- •Willing and able to provide written informed consent
排除标准
- •Additional disabilities that would prevent participation in evaluations.
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •Currently participating, or participated in another interventional clinical study/trial in the past 30 days or if less than 30 days, the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
结局指标
主要结局
Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)
时间窗: 6 months
Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.
次要结局
- Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)(6 months)
- Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor(6 months)
- Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor(Baseline (Nucleus 7) and Visit 2 (6 months, CP1110))