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Taking people in FranceNo phase

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

Key facts

Who runs it
MED-EL Elektromedizinische Geräte GmbH
Where
Saint-Etienne, FranceSee the site
Trial code
Status
Recruiting
People taking part
20 people, planned
Started
5 Nov 2024
Expected to end
1 Jan 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FS4 then TFS4 (cochlear implant)
  • TFS4 then FS4 (cochlear implant)
Record updated
20 January 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

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

Who cannot take part

  • 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

Where in France

  • CHU Saint-EtienneSaint-Etienne, FranceContact: Alexandre Karkas, PrTaking people

About the trial

What the trial wants to find out

Main objective:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • FS4 then TFS4Existing treatment, for comparison

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

    Treatment: FS4 then TFS4 (cochlear implant)

  • TFS4 then FS4Existing treatment, for comparison

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

    Treatment: TFS4 then FS4 (cochlear implant)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparison of Speech Understanding Between a Tonotopy-based Bimodal Fitting and a Default Bimodal Fitting in Newly Cochlear-implanted Patients: a Double-blind Randomized Crossover Study.
Record updated
20 January 2026