DRKS00027817招募中未知
A prospective, multi-centre, repeated measures, traditional feasibility study investigating neural health correlates with outcomes and evaluating focused multipolar implementation in the Phoenix Research System for newly implanted adult cochlear implant recipients - NEUROFI
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Individuals aged 18 years and older who have clinically established post-linguistic bilateral sensorineural hearing loss, and who have compromised functional hearing with hearing aids or would receive no benefit with hearing aids and who meet candidacy criteria for cochlear implantation.
- •2) Fluent speaker in the language used to assess clinical performance as judged by the investigator.
- •3) Willing and able to provide written informed consent.
排除标准
- •1) Previous or existing cochlear-implant recipient.
- •2) Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to two years of age as reported by the subject.
- •3) Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL in the better ear.
- •4) Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component post-operatively.
- •5) Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
- •6) Diagnosis of auditory neuropathy.
- •7) Deafness due to lesions of the acoustic nerve or central auditory pathway.
- •8) Medical or psychological conditions that would contraindicate undergoing surgery.
- •9) Women who are pregnant.
- •10) Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
- •11) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
- •12) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- •13) Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- •14) Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
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