About this trial
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.
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
Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
Disqualifiers
Lack of compliance with any inclusion criteria
Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
Implanted with C40+, C40X and C40C
Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
Trial design
Parallel
Treatments tested in this trial
Default CI fitting
DeviceProgramming of cochlear implant speech processor according to standard clinical care
Anatomy-based CI fitting
DeviceProgramming of cochlear implant speech processor with anatomy-based fitting
Treatment groups
Trial outcomes
Primary outcomes
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Secondary outcomes
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Result of the pitch matching test: frequency difference in semitones
Result of the pitch matching test: frequency differences in semitones
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitair Ziekenhuis Brussel
Lead sponsor
University Hospital, Antwerp
Collaborator