Anatomy-Based Fitting in Unexperienced Cochlear Implant Users
- Conditions
- Sensorineural Hearing LossCochlear Implants
- Registration Number
- NCT05451628
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28, FlexSoft or Standard electrode
- Subject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted side
- Audio processor not yet activated on the newly implanted side
- The most apical active electrode contact has to be inserted at least 450°
- Minimum of 10 active channels can be activated
- Fluent in the language of the test centre
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Speech recognition test in quiet (S0): percentage correctly identified phonemes 6 months post-activation
- Secondary Outcome Measures
Name Time Method Result of the pitch matching test: frequency differences in semitones 6 months post-activation Result of the perception of timbre test: Score on Visual Analog Scale (VAS) 6 months post-activation Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure 6 months post-activation Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit 6 months post-activation Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR 6 months post-activation Result of the pitch matching test: frequency difference in semitones 3 months post-activation Result of the speech contrast discrimination test: Psychometric function of phoneme categorization 6 months post-activation Datalogging data: Average numbers of hours per day 6 months post-activation
Trial Locations
- Locations (1)
UZ Brussel
🇧🇪Brussel, Belgium
UZ Brussel🇧🇪Brussel, BelgiumVedat Topsakal, ProfContactEmilie HeuninckContact