Anatomy-based Fitting in Unexperienced Cochlear Implant Users

NCT ID: NCT05684393

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Anatomy based fitting

Group Type: EXPERIMENTAL

frequency distribution type

Intervention 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.

Standard fitting

Group Type: ACTIVE_COMPARATOR

frequency distribution type

Intervention 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.

Interventions

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.

Intervention Type: OTHER

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dominik Riss

OTHER

Sponsor Role: lead

Responsible Party

Dominik Riss

Assoc.-Prof. Priv.-Doz. Dr. med.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Dominik Riss, MD

Role: CONTACT

dominik.riss@meduniwien.ac.at

+43 1 40400 33760

Facility Contacts

Dominik Riss, MD

Role: primary

dominik.riss@meduniwien.ac.at

+4314040033760

Other Identifiers

2131/2021

Identifier Type: -

Identifier Source: org_study_id