Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Percentage of syllable correctly recognized during speech audiometry test
Study Overview
Brief Summary
The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Fluent in French
- •Able to understand written instructions
- •Under French public medical insurance
- •Normal-hearing subjects only:
- •Adult between 18 and 50 years old
- •Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
- •Clear auditory canal and normal eardrum;
- •Average audiometric loss under 20 decibels Hearing Level (dB HL)
- •Cochlear implant users only:
- •Adult between 18 and 60 yo
- •Normal middle ear
- •Used the cochlear implant for more than a year
- •Wearing a device from the company Neurelec/Oticon Medical
Exclusion Criteria
- •Behavioral and/or neurological disorders
- •Proven psychological disorder
- •Use of psychotropic medication
- •People who experience migraine attacks on a regular basis
- •Use of ototoxic medication
- •Exposed to loud noises within the last 72 hours
- •Included in another clinical trial that uses medication
Arms & Interventions
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Intervention: Psychophysical tuning curves in forward masking (Other)
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Intervention: Electrically-evoked Auditory Brainstem Response (EABR) (Other)
Cochlear implant users
Adult cochlear implanted patients wearing an Oticon Medical/Neurelec device will have speech audiometry test in noise, psychophysical tuning curves in forward masking and Electrically-evoked Auditory Brainstem Response (EABR) measurement
Intervention: speech audiometry in noise (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Intervention: speech audiometry in noise (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Intervention: Psychophysical tuning curves in forward masking (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Intervention: Tonal audiometry (Other)
Normal-hearing subjects
Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry
Intervention: Auditory canal examination (Other)
Outcomes
Primary Outcomes
Percentage of syllable correctly recognized during speech audiometry test
Time Frame: At inclusion
Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.
Secondary Outcomes
- Sound masking threshold(At inclusion)
- Electrically-evoked Auditory Brainstem Response (eABR)(Up to 12 months after inclusion)