NCT07703800 The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
| NCT ID | NCT07703800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Cochlear Implant |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-26 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Griet Mertens, Prof.
PRINCIPAL INVESTIGATOR
University Hospital, Antwerp
Frequently Asked Questions
Who can join the NCT07703800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cochlear Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07703800 currently recruiting?
Yes, NCT07703800 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Antwerp to inquire about joining.
Where is the NCT07703800 trial being conducted?
This trial is being conducted at Antwerp, Belgium.
Who is sponsoring the NCT07703800 clinical trial?
NCT07703800 is sponsored by University Hospital, Antwerp. The principal investigator is Griet Mertens, Prof. at University Hospital, Antwerp. The trial plans to enroll 20 participants.