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NCT Number: NCT07703800

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

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.

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Key information

Conditions

Cochlear Implant Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Sensorineural Hearing Loss Signs and Symptoms Single Sided Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hopsital

Antwerp, 2650, Belgium

Location status: Recruiting

Location contact

Emilie Heuninck

CONTACT

[email protected]

00324368422

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Anatomy-based fitting

Device

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

Default fitting

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Pitch ranking

    Time frame: 3 months post-activation

    Frequency difference in semitones between CI and NH

  2. Pitch ranking

    Time frame: 6 months post-activation

    Frequency difference in semitones between CI and NH

  3. Pitch ranking

    Time frame: 12 months post-activation

    Frequency difference in semitones between CI and NH

  4. Perception of timbre

    Time frame: 3 months post-activation

    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.

  5. Perception of timbre

    Time frame: 6 months post-activation

    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.

  6. Perception of timbre

    Time frame: 12 months post-activation

    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.

  7. Localization

    Time frame: 3 months post-activation

    Root mean square localization error (RMSE) in degrees

  8. Localization

    Time frame: 6 months post-activation

    Root mean square localization error (RMSE) in degrees

  9. Localization

    Time frame: 12 months post-activation

    Root mean square localization error (RMSE) in degrees

  10. Melodic interval perception

    Time frame: 3 months post-activation

    Psychometric function of melodic intervals

  11. Melodic interval perception

    Time frame: 6 months post-activation

    Psychometric function of melodic intervals

  12. Melodic interval perception

    Time frame: 12 months post-activation

    Psychometric function of melodic intervals

  13. Sound quality

    Time frame: 3 months post-activation

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

  14. Sound quality

    Time frame: 6 months post-activation

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

  15. Sound quality

    Time frame: 12 months post-activation

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

  16. HISQUI19 questionnaire

    Time frame: 3 months post-activation

    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.

  17. HISQUI19 questionnaire

    Time frame: 6 months post-activation

    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.

  18. HISQUI19 questionnaire

    Time frame: 12 months post-activation

    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.

  19. Speech, Spatial and Qualities of Hearing scale (SSQ12)

    Time frame: 3 months post-activation

    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.

  20. Speech, Spatial and Qualities of Hearing scale (SSQ12)

    Time frame: 6 months post-activation

    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.

  21. Speech, Spatial and Qualities of Hearing scale (SSQ12)

    Time frame: 12 months post-activation

    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.

  22. Music and cochlear implant questionnaire (MCIQ)

    Time frame: 3 months post-activation

    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.

  23. Music and cochlear implant questionnaire (MCIQ)

    Time frame: 6 months post-activation

    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.

  24. Music and cochlear implant questionnaire (MCIQ)

    Time frame: 12 months post-activation

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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