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

Recruiting now

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT05668338

Run by

MED-EL Elektromedizinische Geräte GesmbH

People needed

100

Starts

2017-06-26

Expected to finish

2030-12-01

Last updated by the study team

2026-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Katholisches Klinikum Bochum — Bochum, Germany (enrolling)
• Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde — Dresden, Germany (enrolling)
• Universitätsklinikum der Goethe-Universität — Frankfurt, Germany (enrolling)
• Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg — Heidelberg, Germany (enrolling)
• Klinikum der Universität München Campus Großhadern — München, Germany (enrolling)
• Evangelisches Krankenhaus Oldenburg — Oldenburg, Germany (enrolling)
• Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner" — Rostock, Germany (enrolling)
• Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen — Tübingen, Germany (enrolling)

Full record on ClinicalTrials.gov

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