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MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY

Recruitingn/aAges any - anyAllMED-EL Elektromedizinische Geräte GmbH
NCT05668338 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This Registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects. This is a patient-outcomes Registry for subjects of any age who are provided in routine clinical practice with one or more MED-EL hearing devices. The Registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from MED-EL company. Subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.

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📋 Eligibility rules (as published)
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
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What it tests

  • Implantable or non-implantable MED-EL hearing solution
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Where

8 sites
Katholisches Klinikum Bochum
Bochum, Germany
Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Dresden, Germany
Universitätsklinikum der Goethe-Universität
Frankfurt, Germany
Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg
Heidelberg, Germany
Klinikum der Universität München Campus Großhadern
München, Germany
Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
Rostock, Germany
Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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