Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT05898659
Recruiting Not applicable

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

NCT05898659 · tracked via the Priya Life Science France tracker
Sponsor
MED-EL Elektromedizinische Geräte GmbH
Phase
Not applicable
Started
2023-10-17
Last updated
2026-01-14

Condition(s) studied

Sensorineural Hearing Loss, Bilateral

Investigational drug(s) / intervention(s)

ABFnoS then ABFS (Cochlear implant)ABFS then ABFnoS (Cochlear implant)

ABFnoS then ABFS (Cochlear implant): Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid

ABFS then ABFnoS (Cochlear implant): Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid

Study summary

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS for the auditory skills experienced by the subject.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient (\>= 18 years old) speaking French * Patient who fulfils the criteria for cochlear implantation * Total hearing loss for less than 5 years Exclusion Criteria: * retro-cochlear pathology: auditory neuropathy, vestibular schwannoma * patient with residual hearing \< 70 dB hearing level (HL) at 250 Hz and 500 Hz and \< 80 dB HL at 1000 Hz on the contralateral ear

Primary outcome measure(s)

  • Accuracy of sound localization — at 6 weeks post-activation
    The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.
  • Accuracy of sound localization — at 12 weeks post-activation
    The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Trial sites (1)

FacilityCityRegionStatus
CHU Nice Nice France Recruiting

More MED-EL Elektromedizinische Geräte GmbH trials in France

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy Recruiting
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting Recruiting
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting Recruiting
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms Recruiting

Other trials for the same condition

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy Recruiting
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting Recruiting
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting Recruiting
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms Recruiting
Natural History in Children up to 16 Years With Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05898659 on ClinicalTrials.gov ↗ ← All trials in France