Channel Interaction in Cochlear Implant and Speech Understanding in Noise (2IPIC)

Civil Hospices of Lyon

Status: Completed

Conditions: Cochlear Implants

Treatments: Other: speech audiometry in noise; Other: Psychophysical tuning curves in forward masking; Other: Tonal audiometry; Other: Electrically-evoked Auditory Brainstem Response (EABR); Other: Auditory canal examination

Study type: Interventional

Funder types: Other

Identifiers

NCT03877211

69HCL17_0434

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Cochlear implant users

Experimental group

Description:

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

Treatment:

Other: Electrically-evoked Auditory Brainstem Response (EABR)

Other: Psychophysical tuning curves in forward masking

Other: speech audiometry in noise

Normal-hearing subjects

Active Comparator group

Description:

Normal-hearing subjects will have speech audiometry test in noise, psychophysical tuning curves in forward masking, auditory canal examination and tonal audiometry

Treatment:

Other: Auditory canal examination

Other: Tonal audiometry

Other: Psychophysical tuning curves in forward masking

Other: speech audiometry in noise