Health TrialsbyHealthPanel

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

ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMED-EL Elektromedizinische Geräte GesmbH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

No study population defined

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Implantable or non-implantable MED-EL hearing solution

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Subject Demographics

Time frame
5 years
2

Hearing Threshold level

Audiometry testing (unaided)

Time frame
5 years
3

Speech test

Results from speech tests

Time frame
5 years
4

HISQUI (Hearing Implant Sound Quality Index)

Results from the HISQUI questionnaire

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MED-EL Elektromedizinische Geräte GesmbH

Lead sponsor

Source ClinicalTrials.gov
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