NCT03039283

Retrospective CI532 Hearing Performance

Retrospective Post-market Hearing Performance Outcome in a Cohort of CI532 Recipients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 162 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Nucleus CI532 cochlear implant	Retrospective study of the commercial CI532 cochlear implant

Timeline

• Start date: 2017-03-14
• Primary completion: 2018-08-28
• Completion: 2018-08-28
• First posted: 2017-02-01
• Last updated: 2019-10-30
• Results posted: 2019-10-11

Locations

5 sites across 1 country: Germany