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

Key facts

Who runs it
MED-EL Elektromedizinische Geräte GmbH
Where
Switzerland1 site in 1 countryChoose a country to see its sites
Trial code
Status
Not yet recruiting
People taking part
700 people, planned
Started
Oct 2026
Expected to end
Nov 2026
Type of study
Observational
Treatments tested
  • Cochlear implantation
Record updated
9 September 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Implanted with a MED-EL cochlear implant
  • First implantation at Inselspital Bern
  • Implanted later than 31st December 1995

Who cannot take part

  • Patients implanted with either a custom-made device or with a study device prior CE-marking
  • Lack of compliance with any inclusion criteria

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The group in the trial

  • MED-EL cochlear implant recipients

    The cohort includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996. To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available.

    Treatment: Cochlear implantation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
9 September 2026