Anatomy-based Fitting in Unexperienced Cochlear Implant Users

Study Overview
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Brief Summary
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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).

Official Title
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Anatomy-based Fitting in Unexperienced Cochlear Implant Users

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

Intervention / Treatment
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* Other: frequency distribution type


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The performance with the CI is investigated over time in two groups of freshly implanted CI users. The first group is fitted using the standard frequency-band distribution as implemented in MAESTRO 9 fitting software. In the second group of users, an anatomy-based frequency distribution is used as per anatomy-based fitting in MAESTRO 9.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anatomy based fitting<br> | Other: frequency distribution type<br>* One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.<br>|
| Active Comparator: Standard fitting<br> | Other: frequency distribution type<br>* One group is fitted using channel filterbank frequency distribution based on anatomy data extracted from post-OP CT measurements. The second (control) group is fitted with the standard frequency distribution used in MAESTRO 9 fitting software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word recognition score (WRS) | Percentage of correctly understood monosyllabic words from a list. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech reception threshold (SRT) | German matrix sentence test - speech to noise ratio in dB. | 6 months | 
| Pitch ranking | Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear. | 6 months | 
| Perception of timbre | Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio. | 6 months | 
| Phoneme categorization | Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum. | 6 months | 
| Consonance/difference rating | The degree of modulation of the pleasantness-score across the individual intervals. | 6 months |