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.

Study Overview

• Status: Recruiting
• Conditions: Sensorineural Hearing Loss; Cochlear Implant; Single Sided Deafness
• Intervention / Treatment: Device: Anatomy-based fitting; Device: Default fitting

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • Recruiting
    • Antwerp University Hopsital
    • Contact: Emilie Heuninck; Phone Number: 00324368422; Email: emilie.heuninck@uza.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anatomy-based fitting; Anatomy-based programming of the speech processor of the cochlear implant	Device: Anatomy-based fitting; Anatomy-based programming of the speech processor of the cochlear implant
Active Comparator: Default fitting; Default programming of the speech processor of the cochlear implant according to standard clinical practice	Device: Default fitting; Default programming of the speech processor of the cochlear implant according to standard clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	12 months post-activation of the audioprocessor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pitch ranking	Frequency difference in semitones between CI and NH	3 months post-activation
Pitch ranking	Frequency difference in semitones between CI and NH	6 months post-activation
Pitch ranking	Frequency difference in semitones between CI and NH	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.	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.	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.	12 months post-activation
Localization	Root mean square localization error (RMSE) in degrees	3 months post-activation
Localization	Root mean square localization error (RMSE) in degrees	6 months post-activation
Localization	Root mean square localization error (RMSE) in degrees	12 months post-activation
Melodic interval perception	Psychometric function of melodic intervals	3 months post-activation
Melodic interval perception	Psychometric function of melodic intervals	6 months post-activation
Melodic interval perception	Psychometric function of melodic intervals	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)	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)	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)	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.	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.	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.	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.	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.	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.	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.	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.	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.	12 months post-activation

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Griet Mertens, Prof., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID Numbers: 2025-7636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No