Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding

NCT05754918 | Completed

• 1 other identifier: MED_EL_COFRET_Rennes_study
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: 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

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant strategy; tonotopy-based fitting; fine structure coding

Outcome Measures

Primary Outcomes (2)

• Speech recognition in noise

  The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

  at 6 weeks post-activation

• Speech recognition in noise

  The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

  at 12 weeks post-activation

Secondary Outcomes (8)

• Speech recognition in quiet

  at 6 weeks post-activation

• Speech recognition in quiet

  at 12 weeks post-activation

• Melodic contour test

  at 6 weeks post-activation

• Melodic contour test

  at 12 weeks post-activation

• Qualitative measure of music

  at 6 weeks post-activation

Study Arms (2)

TnoFS then TFS

ACTIVE COMPARATOR

Cochlear Implant with TnoFS first during 6 weeks then with TFS during 6 weeks

Device: TnoFs then TFS (Cochlear implant)

TFS then TnoFS

ACTIVE COMPARATOR

Cochlear Implant with TFS first during 6 weeks then with TnoFS during 6 weeks

Device: TFS then TnoFS (Cochlear implant)

Interventions

TnoFs then TFS (Cochlear implant) DEVICE

Cochlear implant with tonotopy-based fitting without fine structure coding then with fine structure coding

TnoFS then TFS

TFS then TnoFS (Cochlear implant) DEVICE

Cochlear implant with tonotopy-based fitting with fine structure coding then without fine structure coding

TFS then TnoFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (\>= 18 years old) speaking French
• Patient who fulfils the criteria for cochlear implantation
• Total hearing loss for less than 5 years

You may not qualify if:

• retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
• patient with residual hearing \< 60 dB HL at 250 Hz and \< 80 dB HL at 500 Hz

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Gwenaelle Creff, Dr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two arms A and B: Arm A: patient's fitting with tonotopy-based fitting without fine structure coding (TnoFS) --\> 6 weeks use --\> tests and patient's fitting with tonotopy-based fitting with fine structure coding (TFS) --\> 6 weeks use --\> tests; Arm B: patient's fitting with TFS --\> 6 weeks use --\> tests and patient's fitting with TnoFS --\> 6 weeks use --\> tests

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: April 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)