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NCT05684393
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Conditions: Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Dominik Riss
Location: Austria
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).
Eligibility Criteria
Inclusion Criteria:Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)Post-OP CT scan of the CI electrode availableSubject implanted with MED-EL cochlear implant(s)Subjects received a Flex28, FlexSoft and Standard electrodeSubject planned to receive a SONNET 2 or RONDO 3 audio processor on the newly implanted sideAudio processor not yet activated on the newly implanted sideThe most apical active electrode contact has to be inserted at least 450°Minimum of 10 active channels can be activatedFluent in the language of the test centreSigned and dated ICF before the start of any study-specific procedureExclusion Criteria:Lack of compliance with any inclusion criteriaEAS user (user of an EAS audio processor)Implanted with C40+, C40X and C40CImplanted with an ABI or Split electrode arrayAnything 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
Source: ClinicalTrials.gov (NCT05684393). StuddyBuddy aggregates publicly available trial information.