Cochlear ImplantNCT07703800
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
A study testing Anatomy-based fitting and Default fitting in people with Cochlear Implant and Sensorineural Hearing Loss, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant, Sensorineural Hearing Loss, Single Sided Deafness
- 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
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2025to Dec 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 unilateral severe-to-profound sensorineural hearing loss
- Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
- Post-operative Computed Tomography (CT) scan of the CI elec-trode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex20, Flex24, Flex28, FlexSoft, Flex34 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
- Newly implanted CI users
- The most apical active electrode contact has to be inserted at least 540°
- 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
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- 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 study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hopsital
Antwerp, 2650
Emilie Heuninck, 00324368422, emilie.heuninck@uza.be
About this study
The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
- 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
Anatomy-based programming of the speech processor of the cochlear implant
Default fittingDevice
Default programming of the speech processor of the cochlear implant according to standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Anatomy-based fitting | Active comparator | Anatomy-based programming of the speech processor of the cochlear implant Receives: Device: Anatomy-based fitting |
| Default fitting | Active comparator | Default programming of the speech processor of the cochlear implant according to standard clinical practice Receives: Device: Default fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech perception in noise
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Measured: 3 months post-activation of the audioprocessor
Speech perception in noise
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Measured: 6 months post-activation of the audioprocessor
Speech perception in noise
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Measured: 12 months post-activation of the audioprocessor
Secondary outcomes (24)
Pitch ranking
Frequency difference in semitones between CI and NH
Measured: 3 months post-activation
Pitch ranking
Frequency difference in semitones between CI and NH
Measured: 6 months post-activation
Pitch ranking
Frequency difference in semitones between CI and NH
Measured: 12 months post-activation
Perception of timbre
Score on Visual Analog Scale (VAS). Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
Measured: 3 months post-activation
Perception of timbre
Score on Visual Analog Scale (VAS). Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
Measured: 6 months post-activation
Perception of timbre
Score on Visual Analog Scale (VAS). Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.
Measured: 12 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Measured: 3 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Measured: 6 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Measured: 12 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Measured: 3 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Measured: 6 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Measured: 12 months post-activation
Sound quality
Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
Measured: 3 months post-activation
Sound quality
Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
Measured: 6 months post-activation
Sound quality
Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)
Measured: 12 months post-activation
HISQUI19 questionnaire
Total score and classification of self-perceived auditory benefit. The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Measured: 3 months post-activation
HISQUI19 questionnaire
Total score and classification of self-perceived auditory benefit. The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Measured: 6 months post-activation
HISQUI19 questionnaire
Total score and classification of self-perceived auditory benefit. The 19 items are rated on a 7-point Likert scale ranging from always (99%) to never (1%). To calculate the overall score the corresponding numerical value of each item (from always = 7 to never = 1) is added. Uncompleted items and the response option "not applicable" correspond to 0 in this calculation. A total score of less than 30, 30-59, 60-89, 90-109, and 110-133 is respectively classified as a very poor, poor, moderate, good, and very good self-perceived auditory benefit.
Measured: 12 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Total score and score in the speech, spatial and quality domain. The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items. For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Measured: 3 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Total score and score in the speech, spatial and quality domain. The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items. For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Measured: 6 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Total score and score in the speech, spatial and quality domain. The 12 items of this questionnaire are rated on a visual analog scale from 0 to 10 and the overall score is calculated by taking the average of the scores of these 12 items. For the overall score and the score on each subdomain, the score ranges between 0-10 and a higher score indicates a better outcome.
Measured: 12 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
Measured: 3 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
Measured: 6 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Qualitative interpretation of questionnaire subdomains: motivation to listen to music, musical behavior, musical preferences, music perception abilities, sound quality perception, musical background and music rehabilitation.
Measured: 12 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start26 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by University Hospital, AntwerpThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Griet Mertens, Prof., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703800
- Sponsor's protocol ID
- 2025-7636
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT07703800
- Acronym / sponsor ID
- 2025-7636
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 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 present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomy-based fitting | Active comparator | Device: Anatomy-based fittingAnatomy-based programming of the speech processor of the cochlear implant |
| Default fitting | Active comparator | Device: Default fittingDefault programming of the speech processor of the cochlear implant according to standard clinical practice |
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 unilateral severe-to-profound sensorineural hearing loss
- Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)
- Post-operative Computed Tomography (CT) scan of the CI elec-trode available
- Subject implanted with MED-EL cochlear implant(s)
Key exclusion criteria (4 listed)
- Lack of compliance with any inclusion criteria
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- 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 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 fittingAnatomy-based programming of the speech processor of the cochlear implant | Device | Anatomy-based fitting |
| Default fittingDefault programming of the speech processor of the cochlear implant according to standard clinical practice | Device | Default fitting |
Primary outcome
Speech perception in noise
Time frame: 3 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Speech perception in noise
Time frame: 6 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
Speech perception in noise
Time frame: 12 months post-activation of the audioprocessor
Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant
24 secondary outcomes
Pitch ranking
Time frame: 3 months post-activation
Pitch ranking
Time frame: 6 months post-activation
Pitch ranking
Time frame: 12 months post-activation
Perception of timbre
Time frame: 3 months post-activation
Perception of timbre
Time frame: 6 months post-activation
Perception of timbre
Time frame: 12 months post-activation
Localization
Time frame: 3 months post-activation
Localization
Time frame: 6 months post-activation
Localization
Time frame: 12 months post-activation
Melodic interval perception
Time frame: 3 months post-activation
Melodic interval perception
Time frame: 6 months post-activation
Melodic interval perception
Time frame: 12 months post-activation
Sound quality
Time frame: 3 months post-activation
Sound quality
Time frame: 6 months post-activation
Sound quality
Time frame: 12 months post-activation
HISQUI19 questionnaire
Time frame: 3 months post-activation
HISQUI19 questionnaire
Time frame: 6 months post-activation
HISQUI19 questionnaire
Time frame: 12 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Time frame: 3 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Time frame: 6 months post-activation
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Time frame: 12 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Time frame: 3 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Time frame: 6 months post-activation
Music and cochlear implant questionnaire (MCIQ)
Time frame: 12 months post-activation
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 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Implant
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Recruiting
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
Cochlear Implant Users
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
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.
Griet Mertens, Prof. principal investigator
University Hospital, Antwerp
1 site 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 University Hospital, Antwerp at 1 site 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 21 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 1 site 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 perception in noise (time frame: 3 months post-activation of the audioprocessor). The study lists 3 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 21 Jul 2026.