Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT03694704 | Withdrawn

• 1 other identifier: MED-EL_FS_prosody_french_study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution of the results of prosodic tests Evaluate the time evolution of the results of differential frequency threshold test Evaluate the time evolution of vocal audiometric tests in silence and noise Evaluate the correlation between prosodic test results and frequency differential threshold results

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant; stimulation strategy; sound coding strategy

Outcome Measures

Primary Outcomes (1)

• Prosodic test

  Two versions, question and statement, of each of 12 sentences were recorded. The final 24 stimuli were constructed so that members of a question/statement pair were acoustically identical until the final syllable leaving pitch as the only salient cue for discrimination. the 24 sentences were presented in random order to the patient and he has to say if it is a question or a statement. Each good answer is scored 1 yielding a total between 0 and 24

  at 12 month post-activation

Secondary Outcomes (5)

• Differential frequency threshold

  at 6 month post-activation

• Prosodic test

  at 6 month post-activation

• Vocal audiometry in quiet and noise

  at 6 month post-activation

• Differential frequency threshold

  at 12 month post-activation

• Vocal audiometry in quiet and noise

  at 12 month post-activation

Study Arms (1)

CI with FineHearing Strategy

EXPERIMENTAL

cochlear implant with FineHearing strategy

Device: FineHearing strategy

Interventions

FineHearing strategy DEVICE

Cochlear implant with FineHearing strategy

CI with FineHearing Strategy

Eligibility Criteria

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

You may qualify if:

• Patient with MED-EL cochlear implant (Sonnet / Synchrony)
• Adult patient (≥ 18 years old) speaking French
• Patient having an estimate of the optimal size of the electrode for its cochlea with the MED-EL software before their implantation.
• Patient with post-implant audiometry thresholds without cochlear implant \> 80 dB HL on 250 Hz, 500 Hz and 1000 Hz frequencies (no residual hearing)
• Patient with vocal audiometry in quiet on Fournier's disyllabic words ≥ 70% at 6 months post-activation

You may not qualify if:

• Retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

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

Study Officials

• Mathieu Marx, Pr

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

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: September 26, 2018
• First Posted: October 3, 2018
• Study Start: February 28, 2019
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 16, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)