ChiCTR1900021885尚未招募Unknown
Benefits and efficacy of cochlear implant system in subjects with unilateral or asymmetrical acquired sensorineural severe-to-profound hearing loss
未提供1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Word (Disyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield
研究概览
简要总结
To evaluate the benefit and efficacy of cochlear implantation in patients with acquired unilateral or asymmetrical severe-to-profound hearing loss.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 至 70（—）
- 性别
- All
入选标准
- •No previous implant/BAHA experience in the ear to be implanted;
- •6 years of age or older;
- •Severe-to-profound sensorineural hearing loss (pure-tone average thresholds > 80 dB HL at 500, 1000 and 2000 Hz) in the ear to be implanted. Prelingual or Postlingual onset of severe to profound unilateral hearing loss.
- •Arm 1: Duration of deafness ≤ 10 years;
- •Arm 2: Duration of deafness > 10 but ≤ 20 years;
- •Marginal hearing aid benefit, defined as a monosyllabic word recognition score of ≤ 50% in the best-aided condition for the ear to be implanted;
- •Cantonese proficiency;
- •Willingness to participate in all scheduled procedures outlined in the protocol.
排除标准
- •Unilateral deafness resulting from non-intact auditory nerve;
- •Cochlear malformation or obstruction that would preclude full insertion of electrode array;
- •Presence of additional disabilities that would prevent or interfere with participation in the required study procedures;
- •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures;
- •Indication for central auditory lesion or compromised auditory nerve.
研究组 & 干预措施
Hearing loss
Cochlear Implant
结局指标
主要结局
Word (Disyllabic) and sentence (CHINT sentences) at 65 dB SPL in soundfield
时间窗: Post 1,3, 6, 12, 18, and 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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