NCT07582198尚未招募不适用
A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cochlear
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.
The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.
Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Aged 18 years or older, at time of consent.
- •Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
- •At least 18 active electrodes in the test ear.
- •At least 6 months experience with a cochlear implant in the test ear.
- •Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.
- •Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
- •Candidate is a fluent speaker in the language used to assess speech perception performance.
- •Direct access to a compatible smartphone.
- •Willing and able to provide written informed consent.
排除标准
- •Recipients with single-sided deafness as determined by the Investigator.
- •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 Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
研究者
研究点 (1)
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