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

NCT05668338 | Recruiting

• 1 other identifier: MED-EL_CRD_2015_06
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (9)

• Subject Demographics

  5 years

• Hearing Threshold level

  Audiometry testing (unaided)

  5 years

• Speech test

  Results from speech tests

  5 years

• HISQUI (Hearing Implant Sound Quality Index)

  Results from the HISQUI questionnaire

  5 years

• APHAB (Abbreviated Profile of Hearing Aid Benefit)

  Results from the APHAB questionnaire

  5 years

• ASC (Auditory Skills Checklist)

  Results from the ASC questionnaire

  5 years

• APSQ (Audio Processor Satisfaction Questionnaire)

  Results from the APSQ questionnaire

  5 years

• LEAQ (LittlEars Auditory Questionnaire)

  Results from the LEAQ questionnaire

  5 years

• HL-QOL

  Results from the HL-QOL questionnaire

  5 years

Interventions

Implantable or non-implantable MED-EL hearing solution DEVICE

Receipt of an implantable or non-implantable MED-EL hearing solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No study population defined

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (8)

Katholisches Klinikum Bochum

Bochum, 44787, Germany

RECRUITING

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

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum der Goethe-Universität

Frankfurt, 60590, Germany

RECRUITING

Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Klinikum der Universität München Campus Großhadern

München, 81377, Germany

RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, 26122, Germany

RECRUITING

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

Rostock, 18057, Germany

RECRUITING

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

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Polterauer-Neuling, Dr.

  Klinikum der Universität München Campus Großhadern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmine Rinnofner

CONTACT

+43 57 788 1694; jasmine.rinnofner@medel.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 29, 2022
• Study Start: June 26, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)