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

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Unilateral	Cochlear Implant	Unilaterally implanted
Bilateral	Cochlear Implant	Bilaterally implanted simultaneously

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (9): Callier Center
🇺🇸
Dallas, Texas, United States
Texas Children's Hospital
🇺🇸
Houston, Texas, United States
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Nemours Children's Clinic
🇺🇸
Jacksonville, Florida, United States
Dallas Otolaryngology Associates
🇺🇸
Dallas, Texas, United States
London Health Sciences Centre
🇨🇦
London, Ontario, Canada
Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States