Clinical Evaluation of Frequency Allocation for Bimodal CI Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Sound Quality Questionnaire Score while using standard 188 Hz FAT
研究概览
简要总结
This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 or older
- •Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
- •Received a cochlear implant at least 6 months ago and use a hearing aid in the contralateral ear
- •Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
- •Standard FAT use for all programs prior to study participation
- •No known anatomical abnormalities in either ear
- •English speaking
- •No known cognitive impairments
- •At least 25% of subjects should use the Cochlear EA32 electrode
排除标准
- •Under age 18
- •Non-English speaking. Participants that are Non-English speaking are excluded from this study due to the use of speech testing materials that are validated in the English language. Additionally, study team members are not equipped to appropriately score speech testing materials validated in other languages.
- •Cognitively impaired
- •Non-consistent device usage
- •Greater than 70 dB hearing level pure tone average in the contralateral ear
- •Normal hearing or mild hearing loss in the contralateral ear
- •Non-standard FAT programs
- •Use of any frequency transposition programming in hearing aid.
研究组 & 干预措施
Experienced Users
All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.
干预措施: Experimental frequency allocation table (FAT) - 438 Hz (Other)
Experienced Users
All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.
干预措施: Standard FAT - 188 Hz (Other)
结局指标
主要结局
Sound Quality Questionnaire Score while using standard 188 Hz FAT
时间窗: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
Sound Quality Questionnaire Score while using experimental 438 Hz FAT
时间窗: Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)
A questionnaire will be given to the subjects to record their subjective thoughts regarding sound quality and satisfaction with both the experiment FAT and the standard FAT. Questionnaires will be administered double blind. Patients evaluate the 16-item questionnaire using a likert-scale (1-strongly disagree to 5-strongly agree). Lower scores indicate decreased sound quality and satisfaction, while higher scores indicate increased sound quality and satisfaction.
The consonant-nucleus-consonant (CNC) word list score while using standard 188 Hz FAT
时间窗: Baseline
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using standard 188 Hz FAT
时间窗: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
CNC word list score while using experimental 438 Hz FAT
时间窗: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
CNC word lists are used to evaluate the speech perception abilities of people with hearing impairments and cochlear implant users. A CNC score above 50% postoperatively indicates that a patient can communicate without relying too much on lip reading, sign language, or written communication.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using standard 188 Hz FAT
时间窗: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
Bamford-Kowal-Bench (BKB-SIN) speech-in-noise score using experimental 438 Hz FAT
时间窗: Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)
The BKB-SIN speech-in-noise test measures speech perception in noise by assessing a listener's signal-to-noise ratio (SNR) loss. The test results are presented as the SNR loss, which is the amount the signal-to-noise ratio needs to be increased for the listener to correctly repeat 50% of the sentences. A higher SNR loss indicates more difficulty hearing.
次要结局
未报告次要终点