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

NCT ID: NCT05668338

Last Updated: 2025-08-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-26

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum der Goethe-Universität

Frankfurt, , Germany

Site Status RECRUITING

Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Klinikum der Universität München Campus Großhadern

München, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"

Rostock, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jasmine Rinnofner

Role: CONTACT

+43 57 788 1694

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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