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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
Belgium1 site in 1 countryChoose a country to see its sites
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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
21 July 2026