The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Speech perception in noise
研究概览
简要总结
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Post-lingual onset of unilateral severe-to-profound sensorineural hearing loss
- •Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
- •Post-operative Computed Tomography (CT) scan of the CI elec-trode available
- •Subject implanted with MED-EL cochlear implant(s)
- •Subjects received a Flex20, Flex24, Flex28, FlexSoft, Flex34 or Standard electrode
- •Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
- •Newly implanted CI users
- •The most apical active electrode contact has to be inserted at least 540°
- •Minimum of 10 active channels can be activated
- •Fluent in the language of the test centre
- •Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
排除标准
- •Lack of compliance with any inclusion criteria
- •Implanted with C40+, C40X and C40C
- •Implanted with an ABI or Split electrode array
- •Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
研究组 & 干预措施
Anatomy-based fitting
Anatomy-based programming of the speech processor of the cochlear implant
干预措施: Anatomy-based fitting (Device)
Default fitting
Default programming of the speech processor of the cochlear implant according to standard clinical practice
干预措施: Default fitting (Device)
结局指标
主要结局
Speech perception in noise
时间窗: 3 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Speech perception in noise
时间窗: 6 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Speech perception in noise
时间窗: 12 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
次要结局
- Melodic interval perception(3 months post-activation)
- Melodic interval perception(6 months post-activation)
- Melodic interval perception(12 months post-activation)
- Sound quality(3 months post-activation)
- Sound quality(6 months post-activation)
- Sound quality(12 months post-activation)
- Localization(12 months post-activation)
- Pitch ranking(3 months post-activation)
- Pitch ranking(6 months post-activation)
- Pitch ranking(12 months post-activation)
- Perception of timbre(3 months post-activation)
- Perception of timbre(6 months post-activation)
- Perception of timbre(12 months post-activation)
- Localization(3 months post-activation)
- Localization(6 months post-activation)
- Music and cochlear implant questionnaire (MCIQ)(3 months post-activation)
- Music and cochlear implant questionnaire (MCIQ)(6 months post-activation)
- Music and cochlear implant questionnaire (MCIQ)(12 months post-activation)
- HISQUI19 questionnaire(3 months post-activation)
- HISQUI19 questionnaire(6 months post-activation)
- HISQUI19 questionnaire(12 months post-activation)
- Speech, Spatial and Qualities of Hearing scale (SSQ12)(3 months post-activation)
- Speech, Spatial and Qualities of Hearing scale (SSQ12)(6 months post-activation)
- Speech, Spatial and Qualities of Hearing scale (SSQ12)(12 months post-activation)