A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared With the CP1150 Sound Processor and Their Current 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
- Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise)
研究概览
简要总结
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
详细描述
This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.
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
- •Aged 18 years or older
- •Post lingually deafened
- •Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3).
- •At least 6 months experience with a cochlear hearing implant
- •At least 3 months experience with any Nucleus sound processor and SCAN program
- •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, as determined by the Investigator.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
结局指标
主要结局
Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise)
时间窗: During a Single Ad-Hoc Visit (between Day 141 - Day 218)
Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.
次要结局
- Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version)(During Ad-Hoc Visit (anytime between Day 127 - Day 190))
- Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor(2 weeks)
- Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version)(During Ad-Hoc Visit (anytime between Day 127 - Day 190))
- Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor(2 weeks)
- Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise)(During a single Ad-Hoc Visit (anytime between Day 141 - Day 218))
- Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor(During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70))