Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 16
- 主要终点
- Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
研究概览
简要总结
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 7 months to 5 years 11 months of age at the time of implantation
- •Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and
- •For subjects implanted under 12 months of age: bilateral, severe to profound SNHL in the low frequencies
- •For subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies
- •Insufficient functional access to sound with appropriately fit amplification and aural habilitation
- •Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
- •Radiologic evidence of potential for full insertion with one of the included electrode arrays
- •Ability to undergo general anesthesia
- •At least one parent/guardian who is fluent in one of the available languages of the LEAQ
- •Parental commitment to study parameters
排除标准
- •Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
- •Active middle ear infection
- •Permanent conductive hearing loss
- •Treatable mixed hearing loss
- •Current or history of meningitis
- •Common cavity
- •Skin or scalp condition precluding use of external audio processor
- •Suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance
- •ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12 months of age
- •History of prior use of a hearing implant
- •Unrealistic parental/patient expectations
- •Child is not able to complete speech perception testing in English
结局指标
主要结局
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
时间窗: Up to 12 Months Post-Activation
Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.
Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
时间窗: Up to 12 Months Post-Activation
Adverse events will be collected and reported throughout the duration of the study.
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
时间窗: Up to 12 Months Post-Activation
Clinical success defined as a Total Score of 25 or more on the LittLEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills.
次要结局
- Total Score on Auditory Skills Checklist (ASC)(Up to 12 Months Post-Activation)
- Total Score on LittlEARS Auditory Questionnaire (LEAQ)(Up to 12 Months Post-Activation)
- Speech recognition testing in the implanted ear(s)(Up to 12 Month Post-Activation)