NCT05955469

Brief Summary

Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise. Secondary objectives: Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Jan 2027

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

July 13, 2023

Last Update Submit

January 16, 2026

Conditions

Sensorineural Hearing Loss, BilateralBilateral Hearing Loss

Keywords

Cochlear implantBimodal fittingAnatomy-based fitting

Outcome Measures

Primary Outcomes (2)

  • Speech recognition in noise

    The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].

    at 6 weeks post-activation

  • Speech recognition in noise

    The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].

    at 12 weeks post-activation

Secondary Outcomes (4)

  • Speech recognition in quiet

    at 6 weeks post-activation

  • Speech recognition in quiet

    at 12 weeks post-activation

  • Auditory skills experienced by the patient

    at 6 weeks post-activation

  • Auditory skills experienced by the patient

    at 12 weeks post-activation

Study Arms (2)

FS4 then TFS4

ACTIVE COMPARATOR

Cochlear Implant with FS4 first during 6 weeks then with TFS4 during 6 weeks

Device: FS4 then TFS4 (cochlear implant)

TFS4 then FS4

ACTIVE COMPARATOR

Cochlear Implant with TFS4 first during 6 weeks then with FS4 during 6 weeks

Device: TFS4 then FS4 (cochlear implant)

Interventions

TFS4 then FS4 (cochlear implant)DEVICE

Cochlear implant with tonotopy-based fitting then with default fitting

TFS4 then FS4
FS4 then TFS4 (cochlear implant)DEVICE

Cochlear implant with default fitting then with tonotopy-based fitting

FS4 then TFS4

Eligibility Criteria

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

You may qualify if:

  • Adult patient (\>= 18 years old) speaking French
  • Patient who fulfils the criteria for cochlear implantation

You may not qualify if:

  • retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
  • patient with residual hearing \< 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing Loss, Bilateral

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Officials

  • Alexandre Karkas, Pr

    Centre Hospitalier Universitaire de Saint Etienne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Péan, PhD

CONTACT

0603592974vincent.pean@medel.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind study: The patient and the Investigator don't know the fitting.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover Assignment Two arms A and B: Arm A: Bimodal patient's fitting with default fitting (FS4) --\> 6 weeks use --\> tests and bimodal patient's fitting with tonotopy-based fitting (TFS4) --\> 6 weeks use --\> tests; Arm B: Bimodal patient's fitting with TFS4 --\> 6 weeks use --\> tests and bimodal patient's fitting with FS4 --\> 6 weeks use --\> tests
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

November 5, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)