Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms

NCT06737185 | Recruiting

• 1 other identifier: MEDEL_algoevIC_Dijon_study
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear implant with FS4T. Secondary objectives: Comparison of FS4T and EAFS4T settings

• for speech recognition in quiet
• for subjective auditory spatial perception
• for subjective auditory and musical perception

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant; evolutionary algorithms; tonotopy-based fitting

Outcome Measures

Primary Outcomes (1)

• Speech recognition in noise

  HINT-5 min test. Noise level: 60 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 EAFS4T and with FS4T.

  6 weeks after EAFS4T fitting

Secondary Outcomes (4)

• Speech recognition in quiet

  6 weeks after EAFS4T fitting

• Subjective auditory spatial perception

  at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting

• Subjective assessment of auditory perception

  at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting

• Subjective assessment of musical perception

  at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting

Study Arms (1)

EA arm

OTHER

at 6 month post-activation: evolutionary algorithms to modify the tonotopy-based fitting FS4T to give EAFS4T fitting. Participant wears EAFS4T during 6 weeks.

Other: EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting

Interventions

EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting OTHER

Comparison of FS4T and EAFS4T

Also known as: FS4T: tonotopic-based fitting

EA arm

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

You may not qualify if:

• retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

CHU

Dijon, 21000, France

RECRUITING

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

• Alexis BOZORG GRAYELI, Pr

  Centre Hospitalier Universitaire Dijon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Péan, PhD

CONTACT

603592974; vincent.pean@medel.com

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 5, 2024
• First Posted: December 17, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)