Anatomy-Based Fitting in Bimodal Cochlear Implant Users
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- Who runs it
- Universitair Ziekenhuis Brussel
- Trial code
- NCT07691853
- Record updated
- 9 July 2026
- Original description
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.Read full original descriptionShow less
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.
Inclusion: Age ≥ 18 years; Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s); Post-operative Computed Tomography (CT) scan of the CI electrode available; Subject implanted with MED-EL cochlear implant(s); Subject received a Flex28, FlexSoft or Standard electrode; Subject uses a SONNET 2 or RONDO 3 audio processor; Subject has experience of at least 6 months with cochlear implant; The most apical active electrode contact has to be inserted at least 540°; Minimum of 10 active channels are activated; Subject wears an adequately fitted hearing aid on the contralateral side; Fluent in the language of the test centre; Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
Exclusion: Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array; Lack of compliance with any inclusion criteria; Implanted with C40+, C40X and C40C; Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study.