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NCT07691853
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
Conditions: Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Universitair Ziekenhuis Brussel
Location: Antwerp University Hopsital Antwerp
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 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
Source: ClinicalTrials.gov (NCT07691853). StuddyBuddy aggregates publicly available trial information.