Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).
研究概览
简要总结
The aim of this retrospective study is to collect and assess hearing performance data that have been measured by five clinics in Germany as part of their clinical routine in recipients implanted with a commercial CI532.
详细描述
Speech understanding data in quiet and in noise and aided and unaided thresholds, medical history, anomalies in terms of electrode placement are collected through an eCRF. Recipient's device characteristics are collected through cdx files. Surgeon handling and usability of CI532 are collected through paper questionnaire.
The retrospective study is aimed at collection of data for CI532 recipients who have routine hearing measures at pre-implant and post-implant intervals in their medical records.
Patients are approached for study participation by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to conduct adult hearing performance test material
- •Good German language skills to assess clinical hearing performance
- •CI532 recipients assessed via routine clinical measurements at pre implant, and post implant intervals with available data records in hospital files.
- •Patients that have read, understood and signed the patient informed consent.
排除标准
- •Recipients that have participated in the CLTD5446 study.
结局指标
主要结局
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).
时间窗: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions).
时间窗: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. An adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.
时间窗: pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.
时间窗: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet
时间窗: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.
Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.
时间窗: Pre-operatively and at 6 months post-operatively
Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if \>50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.
次要结局
未报告次要终点