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
- 2
- 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
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
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)
- 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)
- Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit(8 months post- activation)