Investigating New Front-end Features in the SONNET 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Oldenburg Sentence Test in noise (S0 N±135)
研究概览
简要总结
Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced.
The focus of the study is on two new front-end features:
- Focused Beamformer - Enhances directional hearing.
- AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of eighteen (18) years at time of enrolment
- •Experienced MED-EL cochlear implant (CI) user (≥ 6 months) for the ear to be tested
- •User of a MED-EL Audio Processor (i.e. a SONNET, SONNET 2, SONNET 3, or RONDO 3 ≥ 3months)
- •Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
- •A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB sound pressure level (SPL) for the ear to be tested (at the last time tested in clinical routine)
- •Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
排除标准
- •Lack of compliance with any inclusion criteria
- •CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)
- •Implanted with C40X, or C40C on the ear to be tested
- •Implanted with an auditory brainstem implant (ABI) or Split electrode array
- •Known allergic reactions to components of the investigational medical device
- •Anything that, in the opinion of the Investigator, would
- •place the subject at increased risk
- •preclude the subject's full compliance with or completion of the study
研究组 & 干预措施
Adult MED-EL Cochlear implant users with post-lingual, severe to profound sensory-neural hearing los
Testing new versus approved front-end features (within subject design)
干预措施: Testing new front-end features (Other)
结局指标
主要结局
Oldenburg Sentence Test in noise (S0 N±135)
时间窗: immediately after the intervention
Speech perception in noise measured in dB SNR (the new Focused beamformer and the Omnidirectional setting are tested)
次要结局
- Oldenburg Sentence Test in noise (S0 N±135)(immediately after the intervention)