Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding
Key facts
- Who runs it
- MED-EL Elektromedizinische Geräte GmbH
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 21 people enrolled
- Started
- 15 Apr 2023
- Ended
- 1 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TnoFs then TFS (Cochlear implant)
- TFS then TnoFS (Cochlear implant)
- Record updated
- 8 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adult patient (>= 18 years old) speaking French
- Patient who fulfils the criteria for cochlear implantation
- Total hearing loss for less than 5 years
Who cannot take part
- retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
- patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Brief Summary:
Read full original descriptionShow less
Main objective:
Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise.
Secondary objectives:
Comparison of TFS to TnoFS for the perception of musical elements (contour test).
Comparison of TFS to TnoFS for speech perception in quiet
Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces.
Comparison of TFS to TnoFS for the melodic recognition
The 2 groups in the trial
- TnoFS then TFSExisting treatment, for comparison
Cochlear Implant with TnoFS first during 6 weeks then with TFS during 6 weeks
Treatment: TnoFs then TFS (Cochlear implant)
- TFS then TnoFSExisting treatment, for comparison
Cochlear Implant with TFS first during 6 weeks then with TnoFS during 6 weeks
Treatment: TFS then TnoFS (Cochlear implant)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Speech Understanding and Melodic Perception of Two Tonotopic Fitting Modalities With or Without Fine Structure in Newly Implanted Cochlear Patients: Randomized Double-blind Crossover Study.
- Record updated
- 8 April 2025