Conductive Hearing LossNCT07906314
Post-Market Registry Study for Vibrant Hearing Solutions
An observational study of Conductive Hearing Loss and Mixed Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
Trial summary
This observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Conductive Hearing Loss, Mixed Hearing Loss, Sensorineural Hearing Loss
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2026to 20 Jul 2037
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants of any age who are treated in routine clinical care with a CE-marked MED-EL implantable or non-implantable hearing solution, used according to its intended purpose, may be included. No additional burdensome or invasive procedures beyond standard clinical care and normal device use are required.
Who may be able to join
- Adults (18 years or older) and children already treated or in the case a treatment is planned with a CE marked MED-EL Hearing Solution in the respective indication criteria.
- Signed and dated informed consent before the start of any registry- specific procedure and collection of any data.
- Ability to respond to self-administered rating scales or ability of the parent/legal guardian to respond as a proxy to questionnaires for users of MED-EL hearing solutions unable to do so.
Who cannot join
- Lack of compliance with any inclusion criteria.
- Hearing solutions without CE-Mark or that are no longer marketed
- Hearing solutions with initial market entry exceeding 10 years at time of enrolment
- Anything that, in the opinion of the Investigator would place the participant at increased risk or preclude the participant's full compliance with or completion of the registry procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Hals-Chirurgie, Universitätsklinikum Würzburg
Würzburg, Germany, 97080
About this study
This observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care. Participants will be followed long term, potentially up to the lifetime of their hearing solution, to assess quality of life, hearing and speech performance, and device use. Data will be collected using routinely administered clinical tests and questionnaires to evaluate real-world outcomes across diverse populations and MED-EL hearing systems.
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Sensorineural Hearing Loss, Single Sided Deafness
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AMEI | VSB | |
| BCI | BB | |
| BCD | Adhear | |
| PMEI | PMEI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported hearing benefit
Patient reported speech, spatial and qualities of hearing and auditory performance will be assessed by the Speech, Spatial, and Qualities of Hearing questionnaire (SSQ-12 or SSQ P).
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Secondary outcomes (5)
Patient reported health status
Patient reported health status will be assessed by the Glasgow Benefit Inventory (GBI or GCBI).
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Hearing improvement
Hearing improvement will be assessed by sound field thresholds (SF).
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Speech intelligibility
Speech intelligibility will be assessed by the word recognition score (WRS).
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Speech intelligibility
Speech intelligibility will be assessed by the speech reception threshold in quiet (SRT) and in noise (SNR)
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Preservation of hearing thresholds
Preservation of hearing thresholds will be assessed by air conduction thresholds (AC) and /or bone conduction (BC) thresholds.
Measured: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion20 Jul 2036 (estimated)
- Study completion20 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906314
- Sponsor's protocol ID
- REG001
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Registry Study for Vibrant Hearing Solutions
- ClinicalTrials.gov ID
- NCT07906314
- Acronym / sponsor ID
- REG001
- Conditions
- Conductive Hearing Loss, Mixed Hearing Loss, Sensorineural Hearing Loss, Single Sided Deafness
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 20 Jul 2036 (estimated)
- Study completion
- 20 Jul 2037 (estimated)
- First posted
- 30 Oct 2026 (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 observational registry collects retrospective and prospective, data from children and adults who use CE-marked MED-EL implantable (PMEI, BCI, or AMEI) or non-implantable (BCD) hearing solutions as part of routine care. Participants will be followed long term, potentially up to the lifetime of their hearing solution, to assess quality of life, hearing and speech performance, and device use. Data will be collected using routinely administered clinical tests and questionnaires to evaluate real-world outcomes across diverse populations and MED-EL hearing systems.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMEI | – | –VSB |
| BCI | – | –BB |
| BCD | – | –Adhear |
| PMEI | – | –PMEI |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants of any age who are treated in routine clinical care with a CE-marked MED-EL implantable or non-implantable hearing solution, used according to its intended purpose, may be included. No additional burdensome or invasive procedures beyond standard clinical care and normal device use are required.
Key inclusion criteria (3 listed)
- Adults (18 years or older) and children already treated or in the case a treatment is planned with a CE marked MED-EL Hearing Solution in the respective indication criteria.
- Signed and dated informed consent before the start of any registry- specific procedure and collection of any data.
- Ability to respond to self-administered rating scales or ability of the parent/legal guardian to respond as a proxy to questionnaires for users of MED-EL hearing solutions unable to do so.
Key exclusion criteria (4 listed)
- Lack of compliance with any inclusion criteria.
- Hearing solutions without CE-Mark or that are no longer marketed
- Hearing solutions with initial market entry exceeding 10 years at time of enrolment
- Anything that, in the opinion of the Investigator would place the participant at increased risk or preclude the participant'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.
Primary outcome
Patient reported hearing benefit
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Patient reported speech, spatial and qualities of hearing and auditory performance will be assessed by the Speech, Spatial, and Qualities of Hearing questionnaire (SSQ-12 or SSQ P).
5 secondary outcomes
Patient reported health status
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Hearing improvement
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Speech intelligibility
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Speech intelligibility
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
Preservation of hearing thresholds
Time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.
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 30 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conductive Hearing Loss and Mixed Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported hearing benefit (time frame: Data may be analysed at predefined follow-up intervals corresponding to the following time periods after treatment: 0 to 3 months, >3 to 12 months, >12 to 24 months, >24 to 60 months, and beyond 60 months.). 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 30 Oct 2026.