Anatomy-Based Fitting in Bimodal Cochlear Implant Users

July 7, 2026 updated by: Universitair Ziekenhuis Brussel
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e. wearing a cochlear implant and a contralateral hearing aid. Speech perception in quiet, speech perception in noise, consonant/vowel discrimination and pitch/timbre perception will be assessed in an acute set-up with both the default fitting map and the anatomy-based fitting map.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Recruiting
        • Antwerp University Hopsital
        • Contact:
      • Brussels, Belgium, 1090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)
  • Post-operative Computed Tomography (CT) scan of the CI electrode available
  • Subject implanted with MED-EL cochlear implant(s)
  • Subject received a Flex28, FlexSoft or Standard electrode
  • Subject uses a SONNET 2 or RONDO 3 audio processor
  • Subject has experience of at least 6 months with cochlear implant
  • The most apical active electrode contact has to be inserted at least 540°
  • Minimum of 10 active channels are activated
  • Subject wears an adequately fitted hearing aid on the contralateral side
  • Fluent in the language of the test centre
  • Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria
  • Implanted with C40+, C40X and C40C
  • Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array
  • Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First default fitting, then anatomy-based fitting
Device: Anatomy-based fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Device: Default fitting
Programming of cochlear implant speech processor according to standard clinical care
Active Comparator: First anatomy-based fitting, then default fitting
Device: Anatomy-based fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Device: Default fitting
Programming of cochlear implant speech processor according to standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition test in quiet
Time Frame: Day 1 (single study visit), post intervention
Percentage correctly identified phonemes
Day 1 (single study visit), post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech recognition test in noise (S0N0, S0N90)
Time Frame: Day 1 (single study visit), post- intervention
Speech reception threshold in dB SNR
Day 1 (single study visit), post- intervention
Vowel and consonant identification task (ASSE)
Time Frame: Day 1 (single study visit), post-intervention
Number of correctly identified vowels and correctly identified consonants
Day 1 (single study visit), post-intervention
Pitch and timbre ranking
Time Frame: Day 1 (single study visit), post intervention
Score on visual analog scale (VAS) with a range from 0 (duller than the reference) to 10 (brighter than the reference). The score of 5 means an exact match with the timbre or pitch of the hearing aid.
Day 1 (single study visit), post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-2024-063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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