NCT07691853

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2024Dec 2026

Study Start

First participant enrolled

July 1, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.4 years

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Cochlear ImplantSensorineural Hearing LossHearing Aid

Outcome Measures

Primary Outcomes (1)

  • Speech recognition test in quiet

    Percentage correctly identified phonemes

    Day 1 (single study visit), post intervention

Secondary Outcomes (3)

  • Speech recognition test in noise (S0N0, S0N90)

    Day 1 (single study visit), post- intervention

  • Vowel and consonant identification task (ASSE)

    Day 1 (single study visit), post-intervention

  • Pitch and timbre ranking

    Day 1 (single study visit), post intervention

Study Arms (2)

First default fitting, then anatomy-based fitting

ACTIVE COMPARATOR
Device: Anatomy-based fittingDevice: Default fitting

First anatomy-based fitting, then default fitting

ACTIVE COMPARATOR
Device: Anatomy-based fittingDevice: Default fitting

Interventions

Anatomy-based fittingDEVICE

Programming of cochlear implant speech processor with anatomy-based fitting

First anatomy-based fitting, then default fittingFirst default fitting, then anatomy-based fitting
Default fittingDEVICE

Programming of cochlear implant speech processor according to standard clinical care

First anatomy-based fitting, then default fittingFirst default fitting, then anatomy-based fitting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antwerp University Hopsital

Antwerp, 2650, Belgium

RECRUITING

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 9, 2026

Study Start

July 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)