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Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Summary
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.
Official title: Bern Long-term Performance and Safety of MED-EL Cochlear Implants: a Retrospective Anonymized Analysis of Existing Data From the Local Clinical Database
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
700
Start Date
2026-08
Completion Date
2026-11
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Cochlear implantation
The cochlear implant (CI) is one of the most successful neural prostheses developed to date. It offers artificial hearing to individuals with profound sensorineural hearing loss and with insufficient benefit from conventional hearing aids. The first implants provided a limited sensation of sound. The benefit for users of these early systems was mostly a facilitation of lip-reading based communication rather than an understanding of speech. Considerable progress has been made since then. Today, cochlear implantation is the recommended treatment for subjects presenting with a permanent sensorineural hearing loss. Modern, multichannel implant systems feature complex speech processing strategies, high stimulation rates and multiple sites of stimulation in the cochlea. Equipped with such a state-of-the-art system, the majority of recipients today can communicate orally without visual cues and can even use the telephone.
Locations (1)
Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
Bern, Switzerland