Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting
Contribution to Speech Perception of a Tonotopy-based Fitting for Patients With Cochlear Implants for 6 Months With a Conventional Setting: Prospective Cross-sectional Study
1 other identifier
interventional
25
1 country
1
Brief Summary
Main objective: Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy. Secondary objectives: Comparison of FS4noT and FS4T settings
- for speech recognition in quiet
- for subjective auditory spatial perception
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
December 4, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
May 6, 2026
April 1, 2026
3.5 years
December 4, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speech recognition in noise
Framatrix test. Speech and noise in front the participant (at 1m). Noise level: 65 dB SPL. Speech level: adaptive with the answers of the participant. Result: speech-to-noise ratio (speech reception threshold, SRT50) for 50% of intelligibility in noise. Test with FS4T and with FS4noT
6 weeks after FS4T fitting
Secondary Outcomes (2)
Speech recognition in quiet
6 weeks after FS4T fitting
Subjective auditory spatial perception
At FS4T fitting and 6 weeks after FS4T fitting
Study Arms (1)
ABF arm
OTHERAt 6 month post-activation: tonotopic fitting FS4T the participant wears FS4T during 6 weeks.
Interventions
Comparison of FS4T and FS4noT
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU
Limoges, 87000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karine Aubry, Pr
University Hospital, Limoges
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2024
First Posted
December 9, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share