NL-OMON48826已完成不适用
Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation. - CREST study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear Ltd
- 入组人数
- 15
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
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
- •benefits, risks and limitations that are inherent to the procedure and
- •investigational device
研究者
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