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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Implantable or non-implantable MED-EL hearing solution


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable or non-implantable MED-EL hearing solution|Receipt of an implantable or non-implantable MED-EL hearing solution|

What is the study measuring?
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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 |