Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation
研究概览
简要总结
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
详细描述
Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. Literature showed the EAS stimulation can lead to better speech understanding, especially in noisy situation, and can provide important information about intonating or melodic contours, thus increasing sound quality and music perception.
Objectives The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead.
The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.
Methods Unaided tonal audiograms are measured for cochlear implant candidates with low frequency residual hearing before and after cochlear implantation with the EVO electrode lead.
Aided tonal audiograms and speech intelligibility in quiet and in noise are measured after implantation with the three modes of stimulation (acoustic stimulation AS, electric stimulation ES, and electro-acoustic stimulation EAS).
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
- •Agreement to participate
- •Above 18 years old
- •Candidate for cochlear implantation
- •Residual hearing in low frequencies (auditory thresholds better than or equal to 70 dB up to 500 Hz
- •Native or fluent French speaker
排除标准
- •No affiliation to social security
- •No agreement
- •Vulnerable patient
结局指标
主要结局
Change in pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz between pre and post implantation
时间窗: 2 weeks pre-implantation, 1 month post-implantation, 1, 3, 6 and 12 months post-activation
Change from pre-implantation pure tone audiometric thresholds at 125, 250, 500, 750, 1000, 2000 and 4000 Hz at 1 month post implantation with the EVO electrode lead and at 1, 3, 6 and 12 months post-activation
次要结局
- Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in cocktail party noise with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).(3, 6 and 12 months post activation)
- Surgery questionnaire evaluating the surgical technique, the presence of problems during surgery, the quality of insertion and surgeon satisfaction with multiple choice questions, close questions and scales from 0 to 10.(single evaluation at implantation only)
- Percentage of words and phonemes correctly identify with "Les listes cochléaires de Lafon" presented in quiet with the speech processor providing acoustic stimulation (AS), Electric Stimulation (ES) or electro-acoustic stimulation (EAS).(3, 6 and 12 months post activation)
- Quality of life questionnaire. Evaluation of satisfaction on a scale from 0 (unsatisfactory) to 10 (satisfactory) of everyday life listening situations.(2 weeks pre op, 3, 6 and 12 months post-activation)
- Intonation perception task measuring the JND (just noticeable difference) in frequency necessary to discriminate two sounds(6 and 12 months post activation)