RecruitingNot ApplicableNCT07703800

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


Sponsor

University Hospital, Antwerp

Enrollment

20 participants

Start Date

Jun 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria15

  • 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
  • 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

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Interventions

DEVICEAnatomy-based fitting

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

DEVICEDefault fitting

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


Locations(1)

Antwerp University Hopsital

Antwerp, Belgium

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NCT07703800


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