A Feasibility, Prospective, Repeated-measures, Within-subject, Interventional Study Investigating the Electrical Categorical Loudness Scaling Using the Mobile Research App in the Home and In-clinic Situation in Experienced Adult Cochlear Implant Participants
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
- 3
- 主要终点
- Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.
研究概览
简要总结
This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.
Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase.
The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature.
The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.
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
- •At least three months of experience with the cochlear implant.
- •Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- •Able to be programmed with ACE (Advanced Combination Encoder), a fixed pulse width (PW) MAP with a maximum PW of 50 us per channel and with ≥ 18 enabled channels on the sound processor MAP.
- •Fluent speaker in the language used to conduct the study procedures, as determined by the investigator.
- •Willing and able to provide written informed consent and to comply with all requirements of the protocol.
排除标准
- •Participants programmed with an acoustic component in the tested ear.
- •Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
- •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).
结局指标
主要结局
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.
时间窗: Day 0, Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one on-site session.
时间窗: Day 0, Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.
Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one at home session.
时间窗: Day 0 - Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one at home session.
时间窗: Day 0 - Day 14
To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.
次要结局
- Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session on-site.(Day 0, Day 14)
- Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session at home.(Day 0 - Day 14)
- Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions at home.(14 days)
- Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions on-site.(14 days)
- Correlation coefficient of very soft sounds (loudness category 35) obtained with Fast-ELS obtained during multiple sessions at home.(14 days)
- Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session on-site.(Day 0, Day 14)
- Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session at home.(Day 0 - Day 14)
- Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions on-site.(14 days)