N/A
Completed N=162
Retrospective CI532 Hearing Performance
Source: ClinicalTrials.gov NCT03039283 ↗Enrolled (actual)
162
Serious AEs
—
Results posted
Oct 2019
Primary outcomePrimary: Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions). — 26.1 Percent correct
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions). |
26.1 | — |
| PRIMARY Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions). |
-5.5 | — |
| PRIMARY Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet. |
96 | — |
| PRIMARY Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet |
73.3 | — |
| PRIMARY Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise. |
67 | — |
| PRIMARY Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise. |
75 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03039283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.