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

NCT05668338 · tracked via the Priya Life Science Germany tracker

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Phase

Observational

Started

2017-06-26

Last updated

2026-02-19

Condition(s) studied

Hearing Loss

Investigational drug(s) / intervention(s)

Implantable or non-implantable MED-EL hearing solution

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

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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Subject Demographics — 5 years
Hearing Threshold level — 5 years
Audiometry testing (unaided)
Speech test — 5 years
Results from speech tests
HISQUI (Hearing Implant Sound Quality Index) — 5 years
Results from the HISQUI questionnaire
APHAB (Abbreviated Profile of Hearing Aid Benefit) — 5 years
Results from the APHAB questionnaire
ASC (Auditory Skills Checklist) — 5 years
Results from the ASC questionnaire
APSQ (Audio Processor Satisfaction Questionnaire) — 5 years
Results from the APSQ questionnaire
LEAQ (LittlEars Auditory Questionnaire) — 5 years
Results from the LEAQ questionnaire
HL-QOL — 5 years
Results from the HL-QOL questionnaire

Trial sites (8)

Facility	City	Region	Status
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

More MED-EL Elektromedizinische Geräte GesmbH trials in Germany

Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery. Recruiting

Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement Active, not recruiting

Other trials for the same condition

A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults Starting soon

Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05668338 on ClinicalTrials.gov ↗ ← All trials in Germany