Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
研究概览
简要总结
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. This study will focus on patients that are already implanted with the HEARO robotic system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 severe to profound sensory-neural hearing loss in the implanted ear(s)
- •Subject implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
- •Subject implanted with MED-EL cochlear implant(s) with Flex28, Flex 26 or FlexSoft electrode to obtain maximum cochlear coverage
- •Subject planned to receive a MED-EL SONNET 2 or RONDO 3 audio processor on the newly implanted side
- •Subject is either a user with unilateral implantation, bilateral implantation or a bimodal CI user (unilateral CI user with contralateral ear adequately fitted with a hearing aid)
- •Pre- operative and post-operative CT scan of the temporal bone available
- •Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
- •Audio processor not yet activated on the newly implanted side
- •Minimum of 10 active channels can be activated
- •Fluent in the language of the test centre (Dutch or French)
- •Signed and dated ICF before the start of any study-specific procedure
排除标准
- •Subject is a Single-Sided Deafness (SSD) CI user
- •Subject is an Electric Acoustic Stimulation (EAS) user (with an EAS audio processor)
- •Lack of compliance with any inclusion criteria
- •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
ABF fitting followed by standard fitting
干预措施: Post-operative ABF followed by fitting according to clinical standard (Device)
Standard fitting followed by ABF fitting
干预措施: Fitting according to clinical standard followed by post-operative ABF (Device)
结局指标
主要结局
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
时间窗: 8 months post-activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
时间窗: 3 months post- activation
Speech recognition in noise: Speech Reception Threshold (SRT) in dB SNR
时间窗: 6 months post- activation
次要结局
- Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)(8 months post- activation)
- Speech recognition in quiet: Percentage correctly identified phonemes(8 months post-activation)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(8 months post- activation)
- Speech discrimination: Number of correctly discriminated pairs of phonemes(8 months post- activation)
- Patient reported outcome: Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(8 months post- activation)
- Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain(8 months post- activation)
- Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(6 months post- activation)
- Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)(3 month post- activation)
- Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)(6 months post- activation)
- Speech discrimination: Number of correctly discriminated pairs of phonemes(3 months post- activation)
- Speech discrimination: Number of correctly discriminated pairs of phonemes(6 months post- activation)
- Pure-tone audiometry with CI: Hearing thresholds between 125Hz and 8 kHz (dB HL)(1 month post- activation)
- Speech recognition in quiet: Percentage correctly identified phonemes(3 months post-activation)
- Speech recognition in quiet: Percentage correctly identified phonemes(6 months post-activation)
- Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(Baseline at activation)
- Patient reported outcome- Nijmegen Cochlear Implant Questionnaire (NCIQ): Total score and score in the physical, psychological and social domain(3 months post- activation)
- Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain(Baseline at activation)
- Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain(3 months post- activation)
- Patient reported outcome- Speech, Spatial and Qualities of Hearing scale (SSQ12): Total score and score in the speech, spatial and quality domain(6 months post- activation)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(Baseline at activation)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(3 months post- activation)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(6 months post- activation)