Anatomy-Based Fitting in Bimodal Cochlear Implant Users
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Anatomy-based fitting
DeviceProgramming of cochlear implant speech processor with anatomy-based fitting
Default fitting
DeviceProgramming of cochlear implant speech processor according to standard clinical care
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: First default fitting, then anatomy-based fittingActive comparator 2 interventions
Group B: First anatomy-based fitting, then default fittingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Speech recognition test in quiet
Percentage correctly identified phonemes
Time frame
Day 1 (single study visit), post interventionSecondary outcomes
1
Speech recognition test in noise (S0N0, S0N90)
Speech reception threshold in dB SNR
Time frame
Day 1 (single study visit), post- intervention2
Vowel and consonant identification task (ASSE)
Number of correctly identified vowels and correctly identified consonants
Time frame
Day 1 (single study visit), post-intervention3
Pitch and timbre ranking
Score on visual analog scale (VAS) with a range from 0 (duller than the reference) to 10 (brighter than the reference). The score of 5 means an exact match with the timbre or pitch of the hearing aid.
Time frame
Day 1 (single study visit), post interventionSponsors and contacts
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Universitair Ziekenhuis Brussel
Lead sponsor
University Hospital, Antwerp
Collaborator
Source ClinicalTrials.gov