Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Report on Degree of Hearing as Measured by Pure Tone Audiogram
研究概览
简要总结
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
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
- •Meet current cochlear implant indications at the implanting centre
- •In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
- •Fluent speaker in the local language used to assess clinical performance
- •Eighteen years of age or older at the time of implantation with no upper age limit
排除标准
- •Evidence of hearing loss prior to 5 years of age.
- •Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
- •Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
- •Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
- •Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
- •Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
- •Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
- •Active middle-ear infection,
- •Tympanic membrane perforation
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
- •Unwillingness or inability of the candidate to comply with all investigational requirements.
- •Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
- •Patients with recurrent episodes of bacterial meningitis.
结局指标
主要结局
Report on Degree of Hearing as Measured by Pure Tone Audiogram
时间窗: 6 months and 12 months post activation
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Report on Clinical Performance in Quiet and Noise
时间窗: 3 months, 6 months and 12 months post activation
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Report of Medical/Surgical and Device Related Adverse Events.
时间窗: 12 months post activation.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
次要结局
- Glasgow Benefit Inventory (GBI).(6 months post activation)
- Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)(Preoperative and 6 months post activation)