Anatomy-based Fitting in Unexperienced Cochlear Implant Users

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).

Study Overview

• Status: Recruiting
• Conditions: Influence of Anatomy Based Frequency Mapping on Speech Outcomes and Hearing Related Measures
• Intervention / Treatment: Other: frequency distribution type

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominik Riss, MD; Phone Number: +43 1 40400 33760; Email: dominik.riss@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1180
    • Recruiting
    • Medical University of Vienna
    • Contact: Dominik Riss, MD; Phone Number: +4314040033760; Email: dominik.riss@meduniwien.ac.at
    • Principal Investigator: Dominik Riss, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anatomy based fitting	Other: frequency distribution type; 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.
Active Comparator: Standard fitting	Other: frequency distribution type; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dominik Riss

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: 2131/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No