Anatomy-based Fitting in Unexperienced Cochlear Implant Users

NCT05684393 | Unknown

• 1 other identifier: 2131/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Word recognition score (WRS)

  Percentage of correctly understood monosyllabic words from a list.

  6 months

Secondary Outcomes (5)

• Speech reception threshold (SRT)

  6 months

• Pitch ranking

  6 months

• Perception of timbre

  6 months

• Phoneme categorization

  6 months

• Consonance/difference rating

  6 months

Study Arms (2)

Anatomy based fitting

EXPERIMENTAL

Other: frequency distribution type

Standard fitting

ACTIVE COMPARATOR

Other: frequency distribution type

Interventions

frequency distribution type OTHER

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.

Anatomy based fitting; Standard fitting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dominik Riss: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1180, Austria

RECRUITING

Central Study Contacts

Dominik Riss, MD

CONTACT

+43 1 40400 33760; dominik.riss@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded design: both the participant and the investigator have no information about the treatment group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.-Prof. Priv.-Doz. Dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

AU (1)