A Post-market, Prospective, Observational Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear™ Implants in an Adult Population: a Master Umbrella Investigation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean within-participant change in the word recognition score in quiet
研究概览
简要总结
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems. Speech performance and subjective hearing results, and comparison with cochlear implant results available in literature, is intended to demonstrate the performance and clinical benefit of the cochlear implant systems investigated in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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).
- •Clinically established post-linguistic moderately severe to profound sensorineural hearing loss, in the ear to be implanted.
- •Compromised functional hearing with hearing aid(s) or unlikely to receive benefit with hearing aid(s) in the ear to be implanted.
- •Cochlear implant candidate as determined by the Principal Investigator. Meets local candidacy criteria for cochlear implantation.
- •Candidate is a fluent speaker in the language used to assess speech perception performance.
- •Willing and able to comply with study follow-up schedule.
- •Willing and able to provide written informed consent.
- •Candidate has access to a Smartphone compatible with Nucleus Smart App.
排除标准
- •Prior cochlear implantation in the ear to be implanted.
- •Unrealistic expectations regarding the possible benefit, risks and limitations that are inherent to the surgical procedure and prosthetic device as determined by the investigator.
- •Any contraindications for cochlear implantation listed in the relevant product physician's guide (to be specified per sub-investigation).
- •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 spouse, parent, child or sibling.
- •Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •Women who are pregnant.
- •Current participation, or participation in an 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).
研究组 & 干预措施
Cochlear implant (CI1032)
Participants implanted with a CI1032
干预措施: Cochlear Nucleus Nexa Cochlear implant (CI1032) (Device)
Cochlear implant (CI1022)
Participants implanted with a CI1022
干预措施: Cochlear Nucleus Nexa Cochlear implant (CI1022) (Device)
Cochlear implant (CI1012)
Participants implanted with a CI1012
干预措施: Cochlear Nucleus Nexa Cochlear implant (CI1012) (Device)
结局指标
主要结局
Mean within-participant change in the word recognition score in quiet
时间窗: Preimplantation to 6 months post-activation
Percent correct word score from preimplantation to post-activation in the implanted ear. Score range: 0 to 100% correct, where a higher score is a better outcome.
次要结局
- Incidence of adverse events and device deficiencies(From enrolment to 12 months post-activation)
- Mean within-participant change in Speech Spatial Qualities questionnaire (SSQ-12)(Preimplantation to 3, 6 and 12 months post-activation)
- Mean within-participant change in word recognition score in quiet(Preimplantation to 3 and 12 months post-activation.)
- Mean within-participant change in Living with Cochlear implants questionnaire (LivCI)(Preimplantation to 3, 6 and 12 months post-activation)
- Mean within-subject change in speech recognition threshold in noise(3, 6 and 12 months post-activation)