Observational registry for MED-EL hearing devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects anonymized clinical data from children and adults using MED-EL hearing devices. It aims to gather information on device use, auditory performance, quality of life, and health-related utilities through standardized tests and questionnaires. Participants will be evaluated before implantation or device activation and at follow-up intervals, allowing for comprehensive data analysis on the effectiveness of various hearing solutions. The study is designed to generate hypotheses that can inform future research and clinical practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For children and adults receiving an implant: Subjects submitted or planned to be submitted to unilateral or bilateral implantation, using simultaneous or sequential procedures.
* For children and adults receiving a non-implantable device: Subjects submitted or planned to be submitted to unilateral or bilateral treatment with a non-implantable device from MED-EL.
* Unilateral, bilateral or bimodal users (children and adults) of cochlear implants (CIs), electric-acoustic devices, bone conduction implants, middle ear implants or any other implantable or non-implantable hearing solution from MED-EL.
* Signed written informed consent for data collection for Registry purposes.

Exclusion Criteria:

* Lack of compliance with any inclusion criteria.
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the Registry procedures

Where it's running

• Katholisches Klinikum Bochum
  Bochum, Germany Recruiting
• Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
  Dresden, Germany Recruiting
• Universitätsklinikum der Goethe-Universität
  Frankfurt, Germany Recruiting
• Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg
  Heidelberg, Germany Recruiting
• Klinikum der Universität München Campus Großhadern
  München, Germany Recruiting
• Evangelisches Krankenhaus Oldenburg
  Oldenburg, Germany Recruiting

Study contacts

• Principal investigator: Daniel Polterauer-Neuling, Dr. — Klinikum der Universität München Campus Großhadern
• Study coordinator: Jasmine Rinnofner
• Email: jasmine.rinnofner@medel.com
• Phone: +43 57 788 1694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.