Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Percent correct on AzBio Sentences in Noise
研究概览
简要总结
The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.
详细描述
Participants will be randomized into a starting frequency setting at device activation or shortly after device activation for the first three months of device use. After 3 months listening experience, participants will be randomized into different frequency settings and tested before and after a period of listening experience. Participant outcomes for each of the multiple frequency settings will be evaluated using standard clinical speech testing and through questionnaires designed to capture information about patient sound quality and quality of life.
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)
盲法说明
Participants will be blinded to each of the frequency settings they are utilizing.
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
- •At least 18 years of age
- •Is a cochlear implant candidate as deemed by the participating center
- •Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear.
- •For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
- •Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear.
- •Programmed with electric-only stimulation in the implanted ear
- •The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
- •Post-operative CT scan allows for completion of OTOPLAN analysis
- •ABF settings possible at defaults in clinical programming software
- •Minimum of 10 active electrodes at activation
- •Programmed using a Fine Structure coding strategy
- •English is the primary language
- •Willing and able to comply with all scheduled procedures as defined in the protocol
排除标准
- •Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
- •Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
- •Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
研究组 & 干预措施
Default Clinical Frequency Setting
The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
干预措施: Programming of cochlear implant audio processor frequency settings (Device)
Default Anatomy-Based Fitting
The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software
干预措施: Programming of cochlear implant audio processor frequency settings (Device)
Experimental Anatomy-Based Fitting 1
The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
干预措施: Programming of cochlear implant audio processor frequency settings (Device)
Experimental Anatomy-Based Fitting 2
The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
干预措施: Programming of cochlear implant audio processor frequency settings (Device)
结局指标
主要结局
Percent correct on AzBio Sentences in Noise
时间窗: 3 to 7 months
The AzBio sentence test, consisting of lists of 20 sentences spoken by male and female talkers, will be tested in noise in three spatial listening conditions with after listening experience with each frequency setting. Listening conditions include co-located presentation of the target and noise, target presented with noise to the implanted ear, and target presented with noise to the opposite acoustic hearing ear. Outcomes will be reported as percent correct (%).
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
时间窗: Enrollment to 7 months
Subjects will complete a 35-item questionnaire with a total score ranging from 0-100% (higher score indicates a higher level of functional ability with a cochlear implant) regarding their subjective listening experience in 6 domains: communication, emotional, entertainment, environment, listening effort, social.
次要结局
- Percent Correct on Az Bio Sentences in Noise(12 months)
- Percent Correct on Consonant Nucleus Consonant (CNC) Words(3 to 12 months)
- Post-operative Audiogram(Enrollment and 12 months)
- Subjective feedback questionnaire(Enrollment to 12 months)
- Psychoacoustic Testing of Sound Quality and Preference(7 months)
- Cochlear Implant Quality of Life- 35 Profile (CIQoL35)(12 months)
- Decisional Regret Scale(3 to 12 months)