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Recruiting NCT05668338

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

— Observational Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantable or non-implantable MED-EL hearing solution.
Who it may be relevant to
Registry conditions: Hearing Loss. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Implantable or non-implantable MED-EL hearing solution
    Receipt of an implantable or non-implantable MED-EL hearing solution

Primary outcome measures

  • Subject Demographics [Time frame: 5 years]
  • Hearing Threshold level [Time frame: 5 years]
  • Speech test [Time frame: 5 years]
  • HISQUI (Hearing Implant Sound Quality Index) [Time frame: 5 years]
  • APHAB (Abbreviated Profile of Hearing Aid Benefit) [Time frame: 5 years]
  • ASC (Auditory Skills Checklist) [Time frame: 5 years]
  • APSQ (Audio Processor Satisfaction Questionnaire) [Time frame: 5 years]
  • LEAQ (LittlEars Auditory Questionnaire) [Time frame: 5 years]
  • HL-QOL [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 8 centers
  • Katholisches Klinikum Bochum — Bochum
  • Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenhe — Dresden
  • Universitätsklinikum der Goethe-Universität — Frankfurt
  • Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg — Heidelberg
  • Klinikum der Universität München Campus Großhadern — München
  • Evangelisches Krankenhaus Oldenburg — Oldenburg
  • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Kör — Rostock
  • Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Oper — Tübingen

Identifiers

NCT: NCT05668338 · MED-EL_CRD_2015_06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗