Anatomy-based Fitting in Unexperienced Cochlear Implant Users

Dominik Riss

Status

Enrolling

Conditions

Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures

Treatments

Other: frequency distribution type

Study type

Interventional

Funder types

Other

Identifiers

NCT05684393

2131/2021

Details and patient eligibility

About

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).

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

Exclusion criteria

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