IMPLANTATION WITH MEDTECH COCHLEAR IMPLANT SYSTEM IN ADULTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety – Report of medical/surgical and device related adverse events with regard to type, frequency and seriousness at 3 months post activation
研究概览
简要总结
This study is a Pilot/Feasibility Study,Prospective, Single-center, single arm with sequential enrollment forPerformance and Safety of MedTech Cochlear Implants in the treatment ofSevere-to-profound, sensorineural hearing loss in 3 patients from India.
Performance – To evaluate preoperative to 3 month’spost-activation performance outcomes in the best unilateral listening condition.
Safety – Report of medical/surgical anddevice related adverse events with regard to type, frequency and seriousness at3 months’ post activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.18 years of age or older 2.Severe-to-profound, sensorineural hearing loss (>70 dB), determined by pure tune at 500Hz, 1000Hz and 2000Hz 3.bilateral or Postlingual onset of severe or profound hearing loss 4.Limited benefit from appropriate binaural hearing aids (verified by standard clinical practice), as defined by aided test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tests of open set sentence recognition.
- •Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated 5.Moderate to profound hearing loss in the low frequencies and profound (≥ 90 dB HL) hearing loss in the mid to high speech frequencies 6.eBERA – Electrical brainstem evoked response audiometry to ensure benefit from the Implant.
- •eBERA can be performed during surgery itself.
排除标准
- •1.Sensorineural severe-to-profound hearing loss greater than 20 years at ≥ 2 kHz and above 2.Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted 3.Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery 4.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 5.Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway (audio Neuropathy Spectrum disorder).
- •6.Active middle-ear infection 7.Tympanic membrane perforation 8.Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator 9.Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak 10.Patients with recurrent episodes of bacterial meningitis 11.Any other Cochlear Implant.
结局指标
主要结局
Safety – Report of medical/surgical and device related adverse events with regard to type, frequency and seriousness at 3 months post activation
时间窗: Preoperative to 3 month’s post-activation
Performance – To evaluate preoperative to 3 month’s post-activation performance outcomes in the best unilateral listening condition
时间窗: Preoperative to 3 month’s post-activation
次要结局
- NA(NA)