Anatomy-based Fitting in Unexperienced Cochlear Implant Users
- Conditions
- Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
- Interventions
- Other: frequency distribution type
- Registration Number
- NCT05684393
- Lead Sponsor
- Dominik Riss
- Brief Summary
The present study investigates CI users' potential differences in speech tests, other performance measures (i.e. pitch-matching, perception of timbre and melodic intervals, consonance perception), and patient-reported outcome (i.e. questionnaires) between the clinical fitting map and anatomy-based fitting in two groups of CI users (one with standard fitting and one with anatomy-based fitting).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
- Post-OP CT scan of the CI electrode available
- Subject implanted with MED-EL cochlear implant(s)
- Subjects received a Flex28, FlexSoft and 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 ICF before the start of any study-specific procedure
- Lack of compliance with any inclusion criteria
- EAS user (user of an EAS audio processor)
- Implanted with C40+, C40X and C40C
- Implanted with an ABI or Split electrode array
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard fitting frequency distribution type - Anatomy based fitting frequency distribution type -
- Primary Outcome Measures
Name Time Method Word recognition score (WRS) 6 months Percentage of correctly understood monosyllabic words from a list.
- Secondary Outcome Measures
Name Time Method Speech reception threshold (SRT) 6 months German matrix sentence test - speech to noise ratio in dB.
Pitch ranking 6 months Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.
Perception of timbre 6 months Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.
Phoneme categorization 6 months Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.
Consonance/difference rating 6 months The degree of modulation of the pleasantness-score across the individual intervals.
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria