Anatomy-Based Cochlear Implant Array Selection for Patients With Single-Sided Deafness
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Speech perception in spatially separated noise
研究概览
简要总结
The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.
详细描述
To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.
Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.
All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.
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
- •18 years of age or older at the time of implantation
- •Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater
- •Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less
- •Deemed an appropriate candidate by the investigator
- •Fluent in English
排除标准
- •Duration of profound hearing loss of 10 years or more
- •Sudden onset of hearing loss within six months of implantation
- •Evidence of non-functional cochlear nerve using appropriate imaging modality to be determined by the investigator
- •Other retrocochlear hearing loss
- •Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- •External or middle ear infection
- •Suspected developmental or cognitive concern
- •Other medical contraindication for surgery or anesthesia
研究组 & 干预措施
Anatomy-Based Electrode Selection
For individuals in the anatomy-based electrode (ABE) group, magnetic resolution imaging (MRI) or computed tomography (CT) scans will be evaluated by MED-EL Canada employees. Based on these results, an appropriate electrode array will be selected.
干预措施: Anatomy-Based Electrode Array Selection (Other)
Standard of Care Electrode Selection
The comparison in this study will be to current standard of care, which is to select a single electrode length for most patients, in this case the FLEX28 electrode, which is 28 mm long.
干预措施: Standard of Care Electrode Array Selection (Other)
结局指标
主要结局
Speech perception in spatially separated noise
时间窗: 6 months post activation
Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear
次要结局
- Speech perception in noise(6 months post activation)
- Datalogging(6 months post activation)
- Speech perception in quiet(6 months post activation)
- Speech Spatial and Qualities of Hearing Scale (SSQ)(6 months post activation)