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Cochlear ImplantsABFmultiNCT05451628

Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

A study testing Default CI fitting and Anatomy-based CI fitting in people with Cochlear Implants and Sensorineural Hearing Loss, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cochlear Implants, Sensorineural Hearing Loss
What is being tested?
Default CI fitting and Anatomy-based CI fitting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesBelgium
Study dates
30 Mar 2022to Jan 2027
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
  • Post-operative Computed Tomography (CT) scan of the CI electrode available
  • Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
  • Subject implanted with MED-EL cochlear implant(s)
  • Subjects received a Flex28, FlexSoft or Standard electrode
Show all 12Show fewer
  • Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
  • Audio processor not yet activated on the newly implanted side
  • The most apical active electrode contact has to be inserted at least 450°
  • Minimum of 10 active channels can be activated
  • Fluent in the language of the test centre
  • Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Who cannot join

  • Lack of compliance with any inclusion criteria
  • Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
  • Implanted with C40+, C40X and C40C
  • Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium2 sites, 2 recruiting

  • Antwerp University Hopsital

    Antwerp, 2650

    Griet Mertens, Prof., 003234363245, griet.mertens@uza.be

    Recruiting

  • University Hospital Brussels

    Brussels, Brussels Capital, 1090

    Emilie Heuninck, 003234368422, emilie.heuninck@uzbrussel.be

    Recruiting

Other trials in Belgium

About this study

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Being tested
Default CI fitting, Anatomy-based CI fitting
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Default CI fittingDevice

    Programming of cochlear implant speech processor according to standard clinical care

  • Anatomy-based CI fittingDevice

    Programming of cochlear implant speech processor with anatomy-based fitting

Study groups in NCT05451628
Study groupRoleWhat they receive
Default CI fittingActive comparatorProgramming of cochlear implant speech processor according to standard clinical care
Receives: Device: Default CI fitting
Anatomy-based CI fittingActive comparatorProgramming of cochlear implant speech processor with anatomy-based fitting
Receives: Device: Anatomy-based CI fitting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Measured: 3 months post-activation

  2. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Measured: 6 months post-activation

  3. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Measured: 12 months post-activation

  4. Speech recognition test in quiet (S0): percentage correctly identified phonemes

    Measured: 24 months post-activation

Secondary outcomes (31)

  1. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Measured: 3 months post-activation

  2. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Measured: 6 months post-activation

  3. Result of the pitch matching test: frequency difference in semitones

    Measured: 3 months post-activation

  4. Result of the pitch matching test: frequency differences in semitones

    Measured: 6 months post-activation

  5. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

    Measured: 3 months post-activation

  6. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

    Measured: 6 months post-activation

  7. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Measured: 3 months post-activation

  8. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Measured: 6 months post-activation

  9. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Measured: 3 months post-activation

  10. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Measured: 6 months post-activation

  11. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Measured: 1 day visit (At the activation of the sound processor)

  12. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Measured: 3 months post-activation

  13. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Measured: 6 months post-activation

  14. Datalogging data: Average numbers of hours per day

    Measured: 2 weeks post-activation

  15. Datalogging data: Average numbers of hours per day

    Measured: 1 months post-activation

  16. Datalogging data: Average numbers of hours per day

    Measured: 3 months post-activation

  17. Datalogging data: Average numbers of hours per day

    Measured: 6 months post-activation

  18. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Measured: 12 months post-activation

  19. Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

    Measured: 24 months post-activation

  20. Result of the pitch matching test: frequency differences in semitones

    Measured: 12 months post-activation

  21. Result of the pitch matching test: frequency differences in semitones

    Measured: 24 months post-activation

  22. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

    Measured: 12 months post-activation

  23. Result of the perception of timbre test: Score on Visual Analog Scale (VAS)

    Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.

    Measured: 24 months post-activation

  24. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Measured: 12 months post-activation

  25. Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure

    Measured: 24 months post-activation

  26. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Measured: 12 months post-activation

  27. Result of the speech contrast discrimination test: Psychometric function of phoneme categorization

    Measured: 24 months post-activation

  28. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Measured: 12 months post-activation

  29. Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit

    Measured: 24 months post-activation

  30. Datalogging data: Average numbers of hours per day

    Measured: 12 months post-activation

  31. Datalogging data: Average numbers of hours per day

    Measured: 24 months post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start30 Mar 2022
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451628
Sponsor's protocol ID
EC-2021-437
Acronym
ABFmulti
Status last verified
Dec 2025
First submitted
2 Jun 2022
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Default CI fitting and Anatomy-based CI fitting in people with Cochlear Implants and Sensorineural Hearing Loss, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.

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 12 inclusion and 5 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech recognition test in quiet (S0): percentage correctly identified phonemes (time frame: 3 months post-activation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451628.

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 2 Jul 2026.

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