Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.

Official Title
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Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Cochlear Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12 and 36 months of age at time of implantation Profound bilateral sensorineural hearing loss English as the primary language in the home Realistic expectations of guardians Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills Willing and available to comply with all scheduled procedures as defined in the protocol Audiological: Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually) Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli. All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study. Medical: Good general health status, as judged by Primary Investigator Patent cochleae bilaterally, as indicated by radiological evaluation No contraindications for surgery, in general, or cochlear implant surgery in particular Exclusion Criteria: Prior experience with any cochlear implant system Younger than 12 months or older than 36 months at time of implantation Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy Medical: Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation Abnormal or malformed cochlea(e) to be implanted Severed or non-functional auditory nerve in the ear(s) to be implanted Central auditory lesion Cognitive and/or neurological dysfunction Auditory neuropathy

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral<br>Bilaterally implanted simultaneously | Device: Cochlear Implant<br>* Bilateral Implantation in children<br>* Other names: SonataTI100;|
| Experimental: Unilateral<br>Unilaterally implanted | Device: Cochlear Implant<br>* Bilateral Implantation in children<br>* Other names: SonataTI100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems | Speech perception scores will be compared pre-operatively and postoperatively. | 60 months post initial stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language Acquisition Over Time in Bilaterally Implanted Children. | Scores over time on the MacArthur communicative development inventory. | 60 months post initial activation | 
| Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant. | Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear implant, hearing loss