MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
NCT ID: NCT05668338
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2017-06-26
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Implantable or non-implantable MED-EL hearing solution
Receipt of an implantable or non-implantable MED-EL hearing solution
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Joachim Müller, Prof.Dr.med
Role: PRINCIPAL_INVESTIGATOR
Klinikum der Universität München Campus Großhadern
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Stefan Dazert, Dr.
Role: primary
Marcus Neudert, Dr.
Role: primary
Uwe Baumann, Dr.Ing.
Role: primary
Vera Lohnherr, Dr
Role: primary
Daniel Polterauer, Dr.
Role: primary
Andreas Radeloff, Dr.
Role: primary
Wilma Großmann, Dr.
Role: primary
Hubert Löwenheim, Dr.
Role: primary
Other Identifiers
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MED-EL_CRD_2015_06
Identifier Type: -
Identifier Source: org_study_id
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