Back to resultsAnatomy-based Fitting in Unexperienced Cochlear Implant Users
Primary Purpose
Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
frequency distribution type
Sponsored by
About this trial
This is an interventional basic science trial for Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
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 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
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anatomy based fitting
Standard fitting
Arm Description
Outcomes
Primary Outcome Measures
Word recognition score (WRS)
Percentage of correctly understood monosyllabic words from a list.
Secondary Outcome Measures
Speech reception threshold (SRT)
German matrix sentence test - speech to noise ratio in dB.
Pitch ranking
Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.
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.
Phoneme categorization
Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.
Consonance/difference rating
The degree of modulation of the pleasantness-score across the individual intervals.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05684393
Brief Title
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Official Title
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominik Riss
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
double blinded design: both the participant and the investigator have no information about the treatment group.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anatomy based fitting
Arm Type
Experimental
Arm Title
Standard fitting
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
frequency distribution type
Intervention Description
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.
Primary Outcome Measure Information:
Title
Word recognition score (WRS)
Description
Percentage of correctly understood monosyllabic words from a list.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Speech reception threshold (SRT)
Description
German matrix sentence test - speech to noise ratio in dB.
Time Frame
6 months
Title
Pitch ranking
Description
Difference of the mean ranks for a set of frequencies presented to the tested CI ear and the reference ear.
Time Frame
6 months
Title
Perception of timbre
Description
Visual Analog Scale ratings describing the difference in timbre between the tested CI ear and the reference ear when listening to audio.
Time Frame
6 months
Title
Phoneme categorization
Description
Shape of the psychometric function describing the perception of the /s/-/ʃ/ continuum.
Time Frame
6 months
Title
Consonance/difference rating
Description
The degree of modulation of the pleasantness-score across the individual intervals.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Riss, MD
Phone
+43 1 40400 33760
Email
dominik.riss@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1180
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Riss, MD
Phone
+4314040033760
Email
dominik.riss@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Dominik Riss, MD
12. IPD Sharing Statement
Learn more about this trial
Anatomy-based Fitting in Unexperienced Cochlear Implant Users
We'll reach out to this number within 24 hrs