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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05668338
Other study ID # MED-EL_CRD_2015_06
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 26, 2017
Est. completion date December 2028

Study information

Verified date April 2024
Source MED-EL Elektromedizinische Geräte GesmbH
Contact Jasmine Rinnofner
Phone +43 57 788 1694
Email jasmine.rinnofner@medel.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Katholisches Klinikum Bochum Bochum
Germany Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde Dresden
Germany Universitätsklinikum der Goethe-Universität Frankfurt
Germany Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg Heidelberg
Germany Klinikum der Universität München Campus Großhadern München
Germany Evangelisches Krankenhaus Oldenburg Oldenburg
Germany Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner" Rostock
Germany Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen Tübingen

Sponsors (1)

Lead Sponsor Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject Demographics 5 years
Primary Hearing Threshold level Audiometry testing (unaided) 5 years
Primary Speech test Results from speech tests 5 years
Primary HISQUI (Hearing Implant Sound Quality Index) Results from the HISQUI questionnaire 5 years
Primary APHAB (Abbreviated Profile of Hearing Aid Benefit) Results from the APHAB questionnaire 5 years
Primary ASC (Auditory Skills Checklist) Results from the ASC questionnaire 5 years
Primary APSQ (Audio Processor Satisfaction Questionnaire) Results from the APSQ questionnaire 5 years
Primary LEAQ (LittlEars Auditory Questionnaire) Results from the LEAQ questionnaire 5 years
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