Anatomy-Based Fitting in Unexperienced Cochlear Implant Users (ABFmulti)

June 29, 2026 updated by: Universitair Ziekenhuis Brussel
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (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
  • Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available
  • Subject implanted with MED-EL cochlear implant(s)
  • Subjects received a Flex28, FlexSoft or Standard electrode
  • Subject planned to receive a SONNET 2, SONNET 3 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 Informed Consent Form (ICF) before the start of any study-specific procedure

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria
  • Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)
  • 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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Default CI fitting
Programming of cochlear implant speech processor according to standard clinical care
Device: Default CI fitting
Programming of cochlear implant speech processor according to standard clinical care
Active Comparator: Anatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting
Device: Anatomy-based CI fitting
Programming of cochlear implant speech processor with anatomy-based fitting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame: 3 months post-activation
3 months post-activation
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame: 6 months post-activation
6 months post-activation
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame: 12 months post-activation
12 months post-activation
Speech recognition test in quiet (S0): percentage correctly identified phonemes
Time Frame: 24 months post-activation
24 months post-activation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame: 3 months post-activation
3 months post-activation
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame: 6 months post-activation
6 months post-activation
Result of the pitch matching test: frequency difference in semitones
Time Frame: 3 months post-activation
3 months post-activation
Result of the pitch matching test: frequency differences in semitones
Time Frame: 6 months post-activation
6 months post-activation
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Time Frame: 3 months post-activation
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
3 months post-activation
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Time Frame: 6 months post-activation
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
6 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame: 3 months post-activation
3 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame: 6 months post-activation
6 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame: 3 months post-activation
3 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame: 6 months post-activation
6 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame: 1 day visit (At the activation of the sound processor)
1 day visit (At the activation of the sound processor)
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame: 3 months post-activation
3 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame: 6 months post-activation
6 months post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 2 weeks post-activation
2 weeks post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 1 months post-activation
1 months post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 3 months post-activation
3 months post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 6 months post-activation
6 months post-activation
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame: 12 months post-activation
12 months post-activation
Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR
Time Frame: 24 months post-activation
24 months post-activation
Result of the pitch matching test: frequency differences in semitones
Time Frame: 12 months post-activation
12 months post-activation
Result of the pitch matching test: frequency differences in semitones
Time Frame: 24 months post-activation
24 months post-activation
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Time Frame: 12 months post-activation
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
12 months post-activation
Result of the perception of timbre test: Score on Visual Analog Scale (VAS)
Time Frame: 24 months post-activation
Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, where a higher score reflects a better outcome.
24 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame: 12 months post-activation
12 months post-activation
Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure
Time Frame: 24 months post-activation
24 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame: 12 months post-activation
12 months post-activation
Result of the speech contrast discrimination test: Psychometric function of phoneme categorization
Time Frame: 24 months post-activation
24 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame: 12 months post-activation
12 months post-activation
Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit
Time Frame: 24 months post-activation
24 months post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 12 months post-activation
12 months post-activation
Datalogging data: Average numbers of hours per day
Time Frame: 24 months post-activation
24 months post-activation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitair Ziekenhuis Brussel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Antwerp

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vedat Topsakal, Prof., UZB-VUB

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC-2021-437

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings