A Pivotal, Pre-Market, Prospective, Single-Site, Open-Label, Within-Subject Repeated Measures, Interventional Study of User Acceptance and Speech Perception with the Nucleus 7 Series Sound Processors when used by adult cochlear implant recipients
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Cochlear Ltd
- 入组人数
- 21
研究概览
简要总结
The Nucleus 7 variants, CP1000, CP1001 and CP1002, provide comparable speech perception in quiet. Sentence in noise performance with noise from 3 locations behind the listener showed the benefit of ForwardFocus, available with CP1000, over CP1001 (BEAM) and CP1002 (Zoom) conditions. CP1002 (Zoom) provided a significant benefit over CP1001 (BEAM), which is an unexpected result requiring further bench investigation. Sentence in noise performance with noise from 1 location to the side of the listener showed the benefit of CP1001 (BEAM) over CP1002 (Zoom). When compared to the marketed CP910/920 and CP802, the Nucleus 7 variants provide options for new and existing Nucleus Cochlear Implant recipients. In quiet, all sound processors provided comparable speech perception. In noise, CP1000 with ForwardFocus outperformed all comparators, and all Zoom and BEAM conditions outperformed the CP802 standard. CP910 (BEAM) provided a significant benefit over CP1001 (BEAM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Aged 18 years or older
- •2) Post lingually deafened
- •3) Implanted with the CI500 Series (CI512, CI532, CI522), Freedom
- •Series (CI24RE(CA), CI24RE(ST), CI422), or N24 Series (CI24R(ST), CI24R(CS), CI24R(CA), CI24M) in at least one ear
- •4) At least 6 months experience with a cochlear implant.
- •5) At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor
- •6) Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
- •7) Willingness to participate in and to comply with all requirements of the protocol.
- •8) Fluent speaker in English as determined by the investigator
- •9) Willing and able to provide written informed consent
排除标准
- •1) Additional disabilities that would prevent participation in evaluations.
- •2) Unrealistic expectations on the part of the subject, regarding the
- •possible benefits, risks and limitations that are inherent to the procedures.
- •3) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •4) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •5) Cochlear employees or employees of Contract Research
- •Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •6) Currently participating, or participated within the last 30 days, in
- •another interventional clinical investigation/trial involving an
- •investigational drug or device.