The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
Key facts
- Who runs it
- University Hospital, Antwerp
- Where
- Antwerp, BelgiumSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 26 Jun 2025
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Anatomy-based fitting
- Default fitting
- Record updated
- 21 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Belgium
- Antwerp University HopsitalAntwerp, BelgiumContact: Emilie HeuninckTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Anatomy-based fittingExisting treatment, for comparison
Anatomy-based programming of the speech processor of the cochlear implant
- Default fittingExisting treatment, for comparison
Default programming of the speech processor of the cochlear implant according to standard clinical practice
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 21 July 2026