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

Last updated: December 17, 2024
Sponsor: MED-EL Elektromedizinische Geräte GesmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

Implantable or non-implantable MED-EL hearing solution

Clinical Study ID

NCT05668338
MED-EL_CRD_2015_06
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For children and adults receiving an implant: Subjects submitted or planned to besubmitted to unilateral or bilateral implantation, using simultaneous or sequentialprocedures.

  • For children and adults receiving a non-implantable device: Subjects submitted orplanned to be submitted to unilateral or bilateral treatment with a non-implantabledevice from MED-EL.

  • Unilateral, bilateral or bimodal users (children and adults) of cochlear implants (CIs), electric-acoustic devices, bone conduction implants, middle ear implants orany other implantable or non-implantable hearing solution from MED-EL.

  • Signed written informed consent for data collection for Registry purposes.

Exclusion

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria.

  • Anything that, in the opinion of the Investigator, would place the subject atincreased risk or preclude the subject's full compliance with or completion of theRegistry procedures

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Implantable or non-implantable MED-EL hearing solution
Phase:
Study Start date:
June 26, 2017
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Katholisches Klinikum Bochum

    Bochum, 44787
    Germany

    Active - Recruiting

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

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum der Goethe-Universität

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Klinikum der Universität München Campus Großhadern

    München, 81377
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122
    Germany

    Active - Recruiting

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

    Rostock, 18057
    Germany

    Active - Recruiting

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

    Tübingen, 72076
    Germany

    Active - Recruiting

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