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
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.
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 →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anatomy-based programming of the speech processor of the cochlear implant
Device: Anatomy-based fitting
Default programming of the speech processor of the cochlear implant according to standard clinical practice
Device: Default fitting
Anatomy-based programming of the speech processor of the cochlear implant
Default programming of the speech processor of the cochlear implant according to standard clinical practice
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
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
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
Pitch ranking
Frequency difference in semitones between CI and NH
Time frame: 3 months post-activation
Pitch ranking
Frequency difference in semitones between CI and NH
Time frame: 6 months post-activation
Pitch ranking
Frequency difference in semitones between CI and NH
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Time frame: 3 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Time frame: 6 months post-activation
Localization
Root mean square localization error (RMSE) in degrees
Time frame: 12 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Time frame: 3 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Time frame: 6 months post-activation
Melodic interval perception
Psychometric function of melodic intervals
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-activation
Plan to share: Undecided
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