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โ† Trials
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Anatomy-Based Fitting in Bimodal Cochlear Implant Users

RecruitingNAAges 18 Years - anyAllUniversitair Ziekenhuis Brussel
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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 540ยฐ * 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 Criteria: * Lack of compliance with any inclusion criteria * Implanted with C40+, C40X and C40C * Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array * 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
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What it tests

  • Anatomy-based fitting
  • Default fitting
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Where

2 sites
Antwerp University Hopsital
Antwerp, Belgium
University Hospital Brussels
Brussels, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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