Cochlear ImplantNCT07691853
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
A study testing Anatomy-based fitting and Default fitting in people with Cochlear Implant and Sensorineural Hearing Loss, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial summary
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
- What is being tested?
- Anatomy-based fitting and Default fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jul 2024to 1 Dec 2026
- 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
- Subject implanted with MED-EL cochlear implant(s)
- Subject received a Flex28, FlexSoft or Standard electrode
- Subject uses a SONNET 2 or RONDO 3 audio processor
Show all 12Show fewer
- Subject has experience of at least 6 months with cochlear implant
- The most apical active electrode contact has to be inserted at least 540°
- Minimum of 10 active channels are activated
- Subject wears an adequately fitted hearing aid on the contralateral side
- 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
- 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
- Recruiting
Antwerp University Hopsital
Antwerp, 2650
Griet Mertens, Prof., 0034363245, griet.mertens@uza.be
- Recruiting
University Hospital Brussels
Brussels, 1090
Emilie Heuninck, 003234368422, emilie.heuninck@uzbrussel.be
About this study
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
- Conditions
- Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
- Being tested
- Anatomy-based fitting, Default 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.
Anatomy-based fittingDevice
Programming of cochlear implant speech processor with anatomy-based fitting
Default fittingDevice
Programming of cochlear implant speech processor according to standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| First default fitting, then anatomy-based fitting | Active comparator | Not described Receives: Device: Anatomy-based fitting; Device: Default fitting |
| First anatomy-based fitting, then default fitting | Active comparator | Not described Receives: Device: Anatomy-based fitting; Device: Default fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech recognition test in quiet
Percentage correctly identified phonemes
Measured: Day 1 (single study visit), post intervention
Secondary outcomes (3)
Speech recognition test in noise (S0N0, S0N90)
Speech reception threshold in dB SNR
Measured: Day 1 (single study visit), post- intervention
Vowel and consonant identification task (ASSE)
Number of correctly identified vowels and correctly identified consonants
Measured: Day 1 (single study visit), post-intervention
Pitch and timbre ranking
Score on visual analog scale (VAS) with a range from 0 (duller than the reference) to 10 (brighter than the reference). The score of 5 means an exact match with the timbre or pitch of the hearing aid.
Measured: Day 1 (single study visit), post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691853
- Sponsor's protocol ID
- EC-2024-063
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy-Based Fitting in Bimodal Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT07691853
- Acronym / sponsor ID
- EC-2024-063
- Conditions
- Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Jul 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.
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First default fitting, then anatomy-based fitting | Active comparator | Device: Anatomy-based fitting, Device: Default fitting |
| First anatomy-based fitting, then default fitting | Active comparator | Device: Anatomy-based fitting, Device: Default fitting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Subject implanted with MED-EL cochlear implant(s)
- Subject received a Flex28, FlexSoft or Standard electrode
Key exclusion criteria (4 listed)
- Lack of compliance with any inclusion criteria
- 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
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 |
|---|---|---|
| Anatomy-based fittingProgramming of cochlear implant speech processor with anatomy-based fitting | Device | First anatomy-based fitting, then default fitting, First default fitting, then anatomy-based fitting |
| Default fittingProgramming of cochlear implant speech processor according to standard clinical care | Device | First anatomy-based fitting, then default fitting, First default fitting, then anatomy-based fitting |
Primary outcome
Speech recognition test in quiet
Time frame: Day 1 (single study visit), post intervention
Percentage correctly identified phonemes
3 secondary outcomes
Speech recognition test in noise (S0N0, S0N90)
Time frame: Day 1 (single study visit), post- intervention
Vowel and consonant identification task (ASSE)
Time frame: Day 1 (single study visit), post-intervention
Pitch and timbre ranking
Time frame: Day 1 (single study visit), post intervention
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
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An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomy-based fitting and Default fitting in people with Cochlear Implant 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 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: looking for participants now, as of the sponsor's last update on 9 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 (time frame: Day 1 (single study visit), post intervention). 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 9 Jul 2026.