Status:
TERMINATED
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss
Eligibility:
All Genders
12-36 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00784043
Start Date
March 1 2004
End Date
February 1 2017
Last Update
May 25 2018
Active Locations (9)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30324
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44124
4
Dallas Otolaryngology Associates
Dallas, Texas, United States, 75230