This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
Implanted with a MED-EL cochlear implant
First implantation at Inselspital Bern
Implanted later than 31st December 1995
Lack of compliance with any inclusion criteria
Patients implanted with either a custom-made device or with a study device prior CE-marking
MED-EL Elektromedizinische Geräte GesmbH
Lead sponsor
Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
Collaborator