Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
研究概览
简要总结
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid)
- •Post linguistically deafened adults (≥ 18 years)
- •Unilaterally implanted
- •≤ 15 years of severe to profound deafness prior to implantation
- •Subjects who are capable and willing to participate in speech perception tests in local language
- •Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire)
- •Subjects willing to give their consent to the study
排除标准
- •Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness)
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method
- •Bilateral implantation
- •Hybrid-L (not supported by Nucleus Fitting Software)
- •Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant)
- •Subjects with single-sided deafness
- •Known cochlea malformations
- •Subjects who lost their hearing due to meningitis
研究组 & 干预措施
CSS
Cochlear Nucleus Custom SoundTM Suite
干预措施: CSS (Device)
NFS
Cochlear Nucleus Fitting Software
干预措施: NFS (Device)
结局指标
主要结局
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
时间窗: 15 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
时间窗: 15 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
次要结局
- Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)(15 months after implantation)
- Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire(after each fitting (12 months after implantation))