Place-based Mapping in Electric-acoustic Stimulation Listeners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
研究概览
简要总结
Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.
Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and testing audiologist were blinded to the randomized map for Arm 1 (cochlear implant users with default maps) and Arm 2 (cochlear implant users with place-based maps). Arm 3 is normal hearing participants listening to simulations of default and place-based maps.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz
排除标准
- •Report or present with a cognitive delay or impairment
- •Normal-hearing controls
- •Inclusion Criteria:
- •18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language
- •Exclusion Criteria:
- •Report or present with a cognitive delay or impairment
结局指标
主要结局
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
时间窗: Up to 12 months post-activation
Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)
时间窗: Up to 12 months post-activation
Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)
时间窗: Up to 12 months post-activation
Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).
次要结局
- Perceived Abilities Over Time(Up to 12 months post-activation)