Early Feasibility, Exploratory, Within-subject, Acute Study Comparing the Performance of Different Sound Paths in Adult NeuroZti CI-users
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cochlear
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths
研究概览
简要总结
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
Following Cochlear's acquisition of Neurelec, there is a need to support existing NeuroZti implant users who currently rely on the Neuro 2 sound processor. The Nuc8-based sound processor, currently in development, is designed to be compatible with the Neuro system while integrating with Cochlear's ecosystem of tools and applications developed over the past decade.
To ensure long-term support and maintainability, transitioning to the Nuc8 sound path is preferred. However, changes in sound paths may impact sound quality, speech perception, and user acceptance.
The main question this study aims to answer is: how does speech performance and user satisfaction compare between the Nuc8 and Neu2 sound paths?
Participants will:
- Undergo speech perception testing in quiet environments
- Provide ratings on comfort and overall satisfaction
The study involves a single visit lasting approximately 3 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old at time of consent.
- •Post-lingually deafened.
- •Bilaterally or unilaterally implanted with Oticon Medical Neuro ZTI cochlear implant, using Crystalis with autoXDP (GMCI 'CAP') as the main program, at 500pps stimulation rate. For bilateral CI users, only first-implanted side will be tested.
- •Fluent in French as determined by the investigator.
- •Willing to participate and comply with requirements of the protocol
- •Willing and able to provide written informed consent.
排除标准
- •Additional health complexities that would prevent or restrict participation in the evaluations, including significant visual impairment and/or cognitive impairment.
- •Subjects who have life sustaining devices (such as pacemakers).
- •NeuroZti Subjects with Antenna SD Type.
- •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.
- •Pregnant or breastfeeding women.
- •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).
研究组 & 干预措施
Sound paths in NeuroZti cochlear implant users
NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths.
干预措施: OMRP R2 + Percepolis Accessory Software (Device)
Sound paths in NeuroZti cochlear implant users
NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths.
干预措施: Nuc8 Sound Path (Device)
Sound paths in NeuroZti cochlear implant users
NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths.
干预措施: Neu2 Sound Path (Device)
结局指标
主要结局
Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths
时间窗: Day 0 (Study Visit 1)
This involves testing open-set speech perception performance at simulated input of 65 dB SPL, which represents speech spoken at a normal conversational level. The word test will be performed in the sound field at 0° azimuth. Upon hearing the word, participants are instructed to repeat back the word, and the experimenter will score the recognition correct as either correct (i.e., when the subject repeat the exact word) or incorrect (i.e., when the subject does not repeat the exact word).
次要结局
- Percentage disyllabic word recognition scores in quiet at stimulated input level of 55 dB SPL and at 40 dB SPL for both Nuc8 and Neu2 sound paths(Day 0 (Study Visit 1))
- Occurrence rate of preference using Neu2 and Nuc8 configurations for four subjective preference questions(Day 0 (Study Visit 1))