A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
研究概览
简要总结
This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.
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
- •Aged 18 years or older
- •Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
- •At least 3 months experience with a cochlear hearing implant
- •Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
- •Willingness to participate in and to comply with all requirements of the protocol
- •Fluent speaker in English as determined by the investigator
- •Willing and able to provide written informed consent.
排除标准
- •Additional disabilities that would prevent participation in evaluations
- •Unrealistic expectations on the part of the participant, 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.
- •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
All Participants
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
干预措施: Nucleus 8 Sound Processor streaming via MultiMic+ (Device)
All Participants
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
干预措施: Nucleus 8 Sound Processor microphones (Device)
All Participants
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
干预措施: Nucleus 8 Sound Processor streaming via Roger 20 (Device)
All Participants
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
干预措施: Kanso 3 Sound Processor streaming via Multi-Mic+ (Device)
All Participants
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
干预措施: Kanso 3 Sound Processor microphone (Device)
结局指标
主要结局
Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
时间窗: At ad-hoc visits between enrolment and 12 months
次要结局
- Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Nucleus 8 streaming via the Multi-Mic+ and Nucleus 8 streaming via the Roger 20 system at -15 dB SNR in 65 dB SPL(At ad-hoc visits between enrolment and 12 months)
- Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Kanso 3 streaming via Multi-Mic+ and Kanso 3 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL(At ad-hoc visits between enrolment and 12 months)
- Ratings based on the Device Use Questionnaire after a minimum of two weeks actual-use of the new GN ReSound accessories in the real-world environment(At ad-hoc visits between enrolment and 12 months)