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

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Implantable or non-implantable MED-EL hearing solution

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jasmine Rinnofner; Phone Number: +43 57 788 1694; Email: jasmine.rinnofner@medel.com

Study Locations

• Germany
  • Bochum, Germany, 44787
    • Recruiting
    • Katholisches Klinikum Bochum
    • Contact: Stefan Dazert, Dr.
  • Dresden, Germany, 01307
    • Recruiting
    • Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
    • Contact: Marcus Neudert, Dr.
  • Frankfurt, Germany, 60590
    • Recruiting
    • Universitätsklinikum der Goethe-Universität
    • Contact: Uwe Baumann, Dr.Ing.
  • Heidelberg, Germany, 69120
    • Recruiting
    • Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg
    • Contact: Vera Lohnherr, Dr
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Universität München Campus Grosshadern
    • Contact: Daniel Polterauer, Dr.
  • Oldenburg, Germany, 26122
    • Recruiting
    • Evangelisches Krankenhaus Oldenburg
    • Contact: Andreas Radeloff, Dr.
  • Rostock, Germany, 18057
    • Recruiting
    • Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
    • Contact: Wilma Großmann, Dr.
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen
    • Contact: Hubert Löwenheim, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

No study population defined

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Investigators: Principal Investigator: Daniel Polterauer-Neuling, Dr., Klinikum der Universität München Campus Grosshadern

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: MED-EL_CRD_2015_06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No