ClinicalTrials.gg
RecruitingNCT07703800Updated Jul 21, 2026

The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users

An interventional study of Anatomy-based fitting and Default fitting in Cochlear Implant, Sensorineural Hearing Loss and Single Sided Deafness, sponsored by University Hospital, Antwerp. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2025, registered Jul 2026).
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cochlear Implant
  • Sensorineural Hearing Loss
  • Single Sided Deafness
03

In context

Hearing Loss, Sensorineural

346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.

This study's planned enrollment of 20 is below the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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
  • 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 Form (ICF) before the start of any study-specific procedure

Exclusion criteria

Exclusion Criteria:

  • 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
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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Anatomy-based fitting

    Anatomy-based programming of the speech processor of the cochlear implant

    Device: Anatomy-based fitting

  • Active comparator
    Default fitting

    Default programming of the speech processor of the cochlear implant according to standard clinical practice

    Device: Default fitting

Interventions

  • DeviceAnatomy-based fitting

    Anatomy-based programming of the speech processor of the cochlear implant

  • DeviceDefault fitting

    Default programming of the speech processor of the cochlear implant according to standard clinical practice

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months post-activation of the audioprocessor

  2. 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

    Time frame: 6 months post-activation of the audioprocessor

  3. 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

    Time frame: 12 months post-activation of the audioprocessor

Secondary outcomes

  1. Pitch ranking

    Frequency difference in semitones between CI and NH

    Time frame: 3 months post-activation

  2. Pitch ranking

    Frequency difference in semitones between CI and NH

    Time frame: 6 months post-activation

  3. Pitch ranking

    Frequency difference in semitones between CI and NH

    Time frame: 12 months post-activation

  4. 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.

    Time frame: 3 months post-activation

  5. 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.

    Time frame: 6 months post-activation

  6. 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.

    Time frame: 12 months post-activation

  7. Localization

    Root mean square localization error (RMSE) in degrees

    Time frame: 3 months post-activation

  8. Localization

    Root mean square localization error (RMSE) in degrees

    Time frame: 6 months post-activation

  9. Localization

    Root mean square localization error (RMSE) in degrees

    Time frame: 12 months post-activation

  10. Melodic interval perception

    Psychometric function of melodic intervals

    Time frame: 3 months post-activation

  11. Melodic interval perception

    Psychometric function of melodic intervals

    Time frame: 6 months post-activation

  12. Melodic interval perception

    Psychometric function of melodic intervals

    Time frame: 12 months post-activation

  13. Sound quality

    Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)

    Time frame: 3 months post-activation

  14. Sound quality

    Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)

    Time frame: 6 months post-activation

  15. Sound quality

    Sound quality ratings of four groups of piano samples ranging from consonant (group A) to most dissonant (group D)

    Time frame: 12 months post-activation

  16. 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.

    Time frame: 3 months post-activation

  17. 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.

    Time frame: 6 months post-activation

  18. 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.

    Time frame: 12 months post-activation

  19. 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.

    Time frame: 3 months post-activation

  20. 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.

    Time frame: 6 months post-activation

  21. 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.

    Time frame: 12 months post-activation

  22. 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.

    Time frame: 3 months post-activation

  23. 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.

    Time frame: 6 months post-activation

  24. 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.

    Time frame: 12 months post-activation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07703800
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jun 26, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Griet Mertens, Prof.
principal investigator · University Hospital, Antwerp

Oversight

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

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