Clinical trial NCT05668338: MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
Official title: MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2022-12-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No study population defined

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.


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

Primary outcomes:
measure: Subject Demographics
timeFrame: 5 years
measure: Hearing Threshold level
timeFrame: 5 years
measure: Speech test
timeFrame: 5 years
measure: HISQUI (Hearing Implant Sound Quality Index)
timeFrame: 5 years
measure: APHAB (Abbreviated Profile of Hearing Aid Benefit)
timeFrame: 5 years
measure: ASC (Auditory Skills Checklist)
timeFrame: 5 years
measure: APSQ (Audio Processor Satisfaction Questionnaire)
timeFrame: 5 years
measure: LEAQ (LittlEars Auditory Questionnaire)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
city: Frankfurt
country: Germany
facility: Universitätsklinikum der Goethe-Universität
city: Heidelberg
country: Germany
facility: Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg
city: München
country: Germany
facility: Klinikum der Universität München Campus Großhadern
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Rostock
country: Germany
facility: Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen
Study officials:
affiliation: Klinikum der Universität München Campus Großhadern
name: Joachim Müller, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: