NL-OMON48826
已完成
不适用
Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation. - CREST study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- cochlear monitoring
- 发起方
- Cochlear Ltd
- 入组人数
- 15
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial ended prematurely
研究者
入排标准
入选标准
- •\* Candidate for cochlear implantation according to local indications
- •\* 18 years of age or older at the time of enrolment
- •\* Pre\-operative audiometric threshold in the implanted ear at 500 Hz of better
- •than or equal to 80 dB HL
- •\* Willingness to participate in and to comply with all requirements of the
排除标准
- •\* Prior cochlear implantation in the ear to be implanted
- •\* Ossification or any other cochlear anomaly that might prevent complete
- •insertion of the electrode array
- •\* Abnormal cochlear/nerve anatomy on pre\-operative CT or MRI imaging (excluding
- •a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
- •\* Deafness due to lesions of the acoustic nerve or central auditory pathway
- •\* Diagnosis of auditory neuropathy
- •\* Active middle\-ear infection
- •\* Additional handicaps that would prevent participation in evaluations
- •\* Unrealistic expectations on the part of the subject, regarding the possible
结局指标
主要结局
未指定
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