Observational registry for MED-EL hearing devices

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

This study collects information from children and adults using MED-EL hearing devices to see how well they work and how they improve people's lives.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH (Industry-sponsored)
• Locations: 8 sites (Bochum and 7 other locations)
• Trial ID: NCT05668338 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children and adults who are receiving or planning to receive MED-EL hearing devices, whether implantable or non-implantable.

Not a fit: Patients who do not meet the inclusion criteria or have conditions that may complicate their participation may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance understanding of hearing device effectiveness and improve patient outcomes.

How similar studies have performed: Other observational studies on hearing devices have shown promise in improving patient outcomes, suggesting that this approach could be beneficial.

Eligibility criteria

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 this trial is running

Bochum and 7 other locations

• 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)
• Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner" — Rostock, Germany (Recruiting)
• Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen — Tübingen, Germany (Recruiting)

Study contacts

• Principal investigator: Daniel Polterauer-Neuling, Dr. — Klinikum der Universität München Campus Großhadern
• Study coordinator: Jasmine Rinnofner

Conditions Hearing Loss