Implantation with the HCL Suno/MedTech Cochlear Implant System in Adults and Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Performance To evaluate preoperative to (3 month’s and 5 month’s) post activation performance outcomes in the best unilateral and or bilateral listening condition (based on Unilateral or Bilateral implantation) for the commonly expected outcome (Hearing and Speech Improvement) at the end of third month and fifth month
研究概览
简要总结
This study is a Pivotal Study, Prospective, Multicenter, Non-Randomized, Non-Blinded, single arm study across INDIA including Government & Private sector health care center for safety, performance and effectiveness associated with HCL Suno/ MedTech Cochlear Implant System
Adults:
Performance – To evaluate preoperative to 3 month’s post activation performance outcomes in the best unilateral and/or bilateral listening condition (based on Unilateral or Bilateral implantation) for the commonly expected outcome (Hearing and Speech Improvement) at the end of third month
Safety – Report of medical/surgical and device related adverse events with regard to type, frequency and seriousness at 3 months and 5 months post activation
Effectiveness: Is defined as clinical benefits of greater than 20 % points in terms of improvement at the end of study period when compared with preoperative performance.
Children:
Performance – To evaluate preoperative to 5 month’s post activation performance outcomes in the best unilateral and/or bilateral listening condition (based on Unilateral or Bilateral implantation) for the commonly expected outcome (Hearing and Speech Improvement) at the end of third month and fifth months.
Safety – Report of medical/surgical and device related adverse events with regard to type, frequency and seriousness at 3 months and 5 months post activation.
Effectiveness: Is defined as clinical benefits of greater than 20 % points in terms of improvement at the end of study period when compared with preoperative performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 1.18 years of age or older 2.Severe to profound, sensorineural hearing loss great then 70 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz 3.Postlingual candidates with severe or profound bilateral 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 i.
- •Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level 5.Moderate to profound hearing loss in the low frequencies and profound (≥ 90 dB HL) hearing loss in the mid to high speech frequencies Children 1.Profound bilateral hearing loss in prelingual Children 1years to 06 years.
- •Profound, sensorineural hearing loss greater then 90 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz 2.Severe to profound bilateral hearing loss in Postlingual children 7years to 17 Years.
- •Severe to profound, sensorineural hearing loss greater then 70 dB, determined by pure tune at 500Hz, 1000Hz and 2000Hz 3.Little or no benefit from appropriately fitted hearing aids, which is defined as In younger children less then 4 years of age) A failure to reach developmentally appropriate auditory milestones (such as spontaneous response to name in quiet or to environmental sounds) measured using the Infant Toddler Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or less then 20% correct on a simple open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using monitored live voice (70 dB SPL) In older children (Post Lingual) greater then 7 years of age) Scoring less then 12% on a difficult open-set word recognition test (Phonetically Balanced Kindergarten Test) or less then 30% on an open set sentence test (Hearing in Noise Test for Children) administered using recorded materials in the sound field (70 dB SPL).
排除标准
- •Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
- •2.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.
- •3.Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway (audio Neuropathy Spectrum disorder).
- •4.Active middle-ear infection.
- •5.Tympanic membrane perforation.
- •6.Unwillingness or inability of the candidate to comply with all investigational requirements.
- •7.Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
- •8.Patients with recurrent episodes of bacterial meningitis 9.Any other Cochlear Implant 10.Pregnant women applicable only for adults.
结局指标
主要结局
Performance To evaluate preoperative to (3 month’s and 5 month’s) post activation performance outcomes in the best unilateral and or bilateral listening condition (based on Unilateral or Bilateral implantation) for the commonly expected outcome (Hearing and Speech Improvement) at the end of third month and fifth month
时间窗: Adults 4 months per subject | Children 6 months per subject
Effectiveness Is defined as clinical benefits of greater than 20 % points in terms of improvement at the end of study period when compared with preoperative performance
时间窗: Adults 4 months per subject | Children 6 months per subject
Safety Report of medical or surgical and device related adverse events with regard to type, frequency and seriousness at 3 months and 5 months post activation
时间窗: Adults 4 months per subject | Children 6 months per subject
次要结局
- NA(NA)
研究者
Dr Prahlada NB
Basaveshwara Medical College and Hospital