Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 17
- 试验地点
- 8
- 主要终点
- Change in Adaptive sentence in noise scores (S0N0 test setup)
研究概览
简要总结
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
详细描述
It aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants are blinded to the order of fitting method. Some participants will use first the Behavioural program followed by the investigational program while the other group will use each of these conditions in the opposite order.
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
- •Aged 18 years or older (no upper age limit).
- •Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
- •Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
- •Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- •Willingness to participate in and comply with all requirements of the protocol.
- •Willing and able to provide written informed consent
排除标准
- •Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
- •Subject who will be programmed with an acoustic component in the implanted ear.
- •Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
- •Diagnosis of auditory neuropathy.
- •Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling.
- •Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- •Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). -
研究组 & 干预措施
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.
Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS
干预措施: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software (Device)
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.
Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS
干预措施: Categorical loudness scaling based fitting using the research fitting system. (Device)
结局指标
主要结局
Change in Adaptive sentence in noise scores (S0N0 test setup)
时间窗: 2 days (In booth testing)
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP. Adaptive sentence in noise scores (S0N0 test setup) averaged across the sessions at visit 4 and visit 5.
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
时间窗: 2 days(In booth testing)
To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. Higher the score better the outcome.
Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
时间窗: At visit 4 (week 8) and visit 5 (week 12)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in quiet compared to the behavioural map. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. The higher the score, the better the outcome.
Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
时间窗: At visit 4 (week 8) and visit 5 (week 12)
To determine whether the loudness target (LT) map provides non-inferior speech understanding in noise compared to the behavioural map. Adaptive sentence in noise scores (S0N0 test setup) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB).
次要结局
- Adaptive Digit Triplet Test (DTT) in noise scores(One day (in clinic testing))
- Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings(4 weeks)
- Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL(One day (in booth testing))
- Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)(At visit 4 (week 8) and visit 5 (week 12))
- Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)(Visit 3 (week 4))
- Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)(Visit 3 (week 4))