Retrospective CI532 Hearing Performance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-14

Study Completion Date

2018-08-28

Brief Summary

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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.

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Detailed Description

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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

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Nucleus CI532 cochlear implant

Intervention Type DEVICE

Retrospective study of the commercial CI532 cochlear implant

Interventions

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Nucleus CI532 cochlear implant

Retrospective study of the commercial CI532 cochlear implant

Intervention Type DEVICE

Eligibility Criteria

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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.