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NCT Number: NCT05668338

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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Katholisches Klinikum Bochum, Bochum, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable or non-implantable MED-EL hearing solution

Device

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

Primary outcomes

  1. Subject Demographics

    Time frame: 5 years

  2. Hearing Threshold level

    Time frame: 5 years

    Audiometry testing (unaided)

  3. Speech test

    Time frame: 5 years

    Results from speech tests

  4. HISQUI (Hearing Implant Sound Quality Index)

    Time frame: 5 years

    Results from the HISQUI questionnaire

  5. APHAB (Abbreviated Profile of Hearing Aid Benefit)

    Time frame: 5 years

    Results from the APHAB questionnaire

  6. ASC (Auditory Skills Checklist)

    Time frame: 5 years

    Results from the ASC questionnaire

  7. APSQ (Audio Processor Satisfaction Questionnaire)

    Time frame: 5 years

    Results from the APSQ questionnaire

  8. LEAQ (LittlEars Auditory Questionnaire)

    Time frame: 5 years

    Results from the LEAQ questionnaire

  9. HL-QOL

    Time frame: 5 years

    Results from the HL-QOL questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Jasmine Rinnofner

CONTACT

[email protected]

+43 57 788 1694

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Acronym: MEHS

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Dec 29, 2022
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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