ClinicalTrials.gg
Enrolling by invitationNCT07906314Updated Nov 4, 2026

Post-Market Registry Study for Vibrant Hearing Solutions

An observational study in Conductive Hearing Loss, Mixed Hearing Loss and Sensorineural Hearing Loss, sponsored by MED-EL Elektromedizinische Geräte GmbH. Enrolling by invitation at 1 site in Germany. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by MED-EL Elektromedizinische Geräte GmbH · Observational

Updated Oct 30, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
50
Ages
5 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Conductive Hearing Loss
  • Mixed Hearing Loss
  • Sensorineural Hearing Loss
  • Single Sided Deafness
03

In context

Hearing Loss, Conductive

82 studies on the registry are indexed under Hearing Loss, Conductive; 15 are open to participants now.

This study's planned enrollment of 50 is below the median of 71 across 20 observational studies indexed under Hearing Loss, Conductive.

Browse Hearing Loss, Conductive studies →

Lead sponsor

MED-EL Elektromedizinische Geräte GmbH is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • AMEI

    VSB

  • BCI

    BB

  • BCD

    Adhear

  • PMEI

    PMEI

06

What researchers measure

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Patient reported health status

    Patient reported health status will be assessed by the Glasgow Benefit Inventory (GBI or GCBI).

    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.

  2. Hearing improvement

    Hearing improvement will be assessed by sound field thresholds (SF).

    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.

  3. Speech intelligibility

    Speech intelligibility will be assessed by the word recognition score (WRS). The Word Recognition Score percentage scale ranges from a minimum value of 0%, which means no words were understood, to a maximum value of 100%, which means all words were understood.

    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.

  4. Speech intelligibility

    Speech intelligibility will be assessed by the speech reception threshold in quiet (SRT) and in noise (SNR)

    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.

  5. Preservation of hearing thresholds

    Preservation of hearing thresholds will be assessed by air conduction thresholds (AC) and /or bone conduction (BC) 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.

07

Study locations

1 site
  • Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Hals-Chirurgie, Universitätsklinikum Würzburg
    Würzburg, Germany 97080, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jul 2036, 116 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2026
First posted
Oct 30, 2026
StartEst.
Oct 26, 2026
Primary completionEst.
Jul 20, 2036
CompletionEst.
Jul 20, 2037
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionSpeech intelligibility: how it is measured was reworded
Nov 4, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 4, 2026
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionSpeech intelligibility: how it is measured was reworded
    + 1 other change: verification date
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906314
Lead sponsor
MED-EL Elektromedizinische Geräte GmbH
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Jul 20, 2036 (estimated)
Completion
Jul 20, 2037 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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