Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
研究概览
简要总结
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
- •native speaker in the language used to assess their clinical performance, i.e. French
排除标准
- •unwillingness or inability to comply with all of the investigational requirements
- •additional handicaps that would prevent or restrict participation in the audiological evaluations
研究组 & 干预措施
Firmware N
New feedback canceller algorithm
干预措施: feedback canceller algorithm (Firmware) (Device)
Firmware R
Current feedback canceller algorithm (reference)
干预措施: feedback canceller algorithm (Firmware) (Device)
结局指标
主要结局
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
时间窗: 4 months
次要结局
- Improvement in speech understanding assessed via speech audiometry in noise(4 months)