Hearing LossMEHSNCT05668338
MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
An observational study of Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 8 sites in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Implantable or non-implantable MED-EL hearing solution
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 8 sitesGermany
- Study dates
- 26 Jun 2017to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: No study population defined
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Germany8 sites, 8 recruiting
- Recruiting
Katholisches Klinikum Bochum
Bochum, 44787
Stefan Dazert, Dr.
- Recruiting
Universitätsklinik Carl Gustav Carus - Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Dresden, 01307
Marcus Neudert, Dr.
- Recruiting
Universitätsklinikum der Goethe-Universität
Frankfurt, 60590
Uwe Baumann, Dr.Ing.
- Recruiting
Sektion Otologie und Neuro-Otologie UNI-Klinikum Heidelberg
Heidelberg, 69120
Vera Lohnherr, Dr
- Recruiting
Klinikum der Universität München Campus Großhadern
München, 81377
Daniel Polterauer, Dr.
- Recruiting
Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122
Andreas Radeloff, Dr.
- Recruiting
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie "Otto Körner"
Rostock, 18057
Wilma Großmann, Dr.
- Recruiting
Universitätsklinikum Tübingen, Klinik für Hals-, Nasen- u. Ohrenheilkunde, Plastische Operationen
Tübingen, 72076
Hubert Löwenheim, Dr.
About this 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.
- Conditions
- Hearing Loss
- Being tested
- Implantable or non-implantable MED-EL hearing solution
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable or non-implantable MED-EL hearing solutionDevice
Receipt of an implantable or non-implantable MED-EL hearing solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Demographics
Measured: 5 years
Hearing Threshold level
Audiometry testing (unaided)
Measured: 5 years
Speech test
Results from speech tests
Measured: 5 years
HISQUI (Hearing Implant Sound Quality Index)
Results from the HISQUI questionnaire
Measured: 5 years
APHAB (Abbreviated Profile of Hearing Aid Benefit)
Results from the APHAB questionnaire
Measured: 5 years
ASC (Auditory Skills Checklist)
Results from the ASC questionnaire
Measured: 5 years
APSQ (Audio Processor Satisfaction Questionnaire)
Results from the APSQ questionnaire
Measured: 5 years
LEAQ (LittlEars Auditory Questionnaire)
Results from the LEAQ questionnaire
Measured: 5 years
HL-QOL
Results from the HL-QOL questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start26 Jun 2017
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Polterauer-Neuling, Dr., Principal investigator, Klinikum der Universität München Campus Großhadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668338
- Sponsor's protocol ID
- MED-EL_CRD_2015_06
- Acronym
- MEHS
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MED-EL HEARING SOLUTIONS (MEHS): AN OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT05668338
- Acronym / sponsor ID
- MEHS / MED-EL_CRD_2015_06
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No study population defined
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable or non-implantable MED-EL hearing solutionReceipt of an implantable or non-implantable MED-EL hearing solution | Device | – |
Primary outcome
Subject Demographics
Time frame: 5 years
Hearing Threshold level
Time frame: 5 years
Audiometry testing (unaided)
Speech test
Time frame: 5 years
Results from speech tests
HISQUI (Hearing Implant Sound Quality Index)
Time frame: 5 years
Results from the HISQUI questionnaire
APHAB (Abbreviated Profile of Hearing Aid Benefit)
Time frame: 5 years
Results from the APHAB questionnaire
ASC (Auditory Skills Checklist)
Time frame: 5 years
Results from the ASC questionnaire
APSQ (Audio Processor Satisfaction Questionnaire)
Time frame: 5 years
Results from the APSQ questionnaire
LEAQ (LittlEars Auditory Questionnaire)
Time frame: 5 years
Results from the LEAQ questionnaire
HL-QOL
Time frame: 5 years
Results from the HL-QOL questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Polterauer-Neuling, Dr. principal investigator
Klinikum der Universität München Campus Großhadern
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Rinnofner (+43 57 788 1694, jasmine.rinnofner@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Demographics (time frame: 5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.