Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting

NCT05230498 | Completed

• 1 other identifier: MEDEL_anatfit_Bordeaux_study
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant. Secondary objectives: Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant. Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Conditions

Sensorineural Hearing Loss, Bilateral

Keywords

cochlear implant strategy; anatomy-based fitting

Outcome Measures

Primary Outcomes (2)

• Recognition of Environmental sounds

  The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

  at 6 weeks post-activation

• Recognition of Environmental sounds

  The environmental sound recognition is evaluated with the Environmental Sound Identification Test (TISE, Treville-Protain et al. 2019). The patient has to recognize 24 environmental sounds. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

  at 12 weeks post-activation

Secondary Outcomes (4)

• Speech recognition in quiet

  at 6 weeks post-activation

• Speech recognition in quiet

  at 12 weeks post-activation

• Speech recognition in noise

  at 6 weeks post-activation

• Speech recognition in noise

  at 12 weeks post-activation

Study Arms (2)

Cochlear Implant (CI) with default fitting then anatomy-based fitting

ACTIVE COMPARATOR

Cochlear Implant with default fitting first during 6 weeks then with anatomy-based fitting during 6 weeks

Device: default fitting then anatomy-based fitting

Cochlear Implant (CI) with anatomy-based fitting then default fitting

ACTIVE COMPARATOR

Cochlear Implant with anatomy-based fitting during 6 weeks then with default fitting during 6 weeks

Device: anatomy-based fitting then default fitting

Interventions

anatomy-based fitting then default fitting DEVICE

Cochlear implant with anatomy-based fitting then default fitting

Cochlear Implant (CI) with anatomy-based fitting then default fitting

default fitting then anatomy-based fitting DEVICE

Cochlear implant with anatomy-based fitting then default fitting

Cochlear Implant (CI) with default fitting then anatomy-based fitting

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

Bordeaux, 33076, 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

• Damien Bonnard, Dr

  University Hospital, Bordeaux

  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 default fitting --\> 6 weeks use --\> tests and patient's fitting with anatomy-based fitting --\> 6 weeks use --\> tests Arm B: patient's fitting with anatomy-based fitting --\> 6 weeks use --\> tests and patient's fitting with default fitting --\> 6 weeks use --\> tests

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: February 15, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)