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RecruitingNCT07691853Updated Jul 9, 2026

Anatomy-Based Fitting in Bimodal Cochlear Implant Users

An interventional study of Anatomy-based fitting and Default fitting in Cochlear Implant, Sensorineural Hearing Loss and Hearing Aid, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jul 2024, registered Jun 2026).
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cochlear Implant
  • Sensorineural Hearing Loss
  • Hearing Aid
03

In context

Hearing Loss, Sensorineural

371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.

This study's planned enrollment of 25 is below the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    First default fitting, then anatomy-based fitting

    Device: Anatomy-based fitting · Device: Default fitting

  • Active comparator
    First anatomy-based fitting, then default fitting

    Device: Anatomy-based fitting · Device: Default fitting

Interventions

  • DeviceAnatomy-based fitting

    Programming of cochlear implant speech processor with anatomy-based fitting

  • DeviceDefault fitting

    Programming of cochlear implant speech processor according to standard clinical care

06

What researchers measure

Primary outcomes

  1. Speech recognition test in quiet

    Percentage correctly identified phonemes

    Time frame: Day 1 (single study visit), post intervention

Secondary outcomes

  1. Speech recognition test in noise (S0N0, S0N90)

    Speech reception threshold in dB SNR

    Time frame: Day 1 (single study visit), post- intervention

  2. Vowel and consonant identification task (ASSE)

    Number of correctly identified vowels and correctly identified consonants

    Time frame: Day 1 (single study visit), post-intervention

  3. Pitch and timbre ranking

    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.

    Time frame: Day 1 (single study visit), post intervention

07

Study locations

2 of 2 sites recruiting
  • Antwerp University Hopsital
    Antwerp, 2650, Belgium
    Recruiting
  • University Hospital Brussels
    Brussels, 1090, Belgium
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07691853
Lead sponsor
Universitair Ziekenhuis Brussel
Collaborators
University Hospital, Antwerp
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Jul 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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