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Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.

NCT07777562 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Severe to Profound Hearing Loss

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology

    collaborator UNKNOWN

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777562 on ClinicalTrials.gov