Retrospective CI532 Hearing Performance
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About
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.
Full description
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.
Enrollment
Sex
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- Recipients that have participated in the CLTD5446 study.
Trial design
162 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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