Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
Stopped early · Not applicable
Conditions studied: Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT00784043
- Run by
- Med-El Corporation
- People needed
- 37
- Starts
- 2004-03-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2018-05-25
Who can join
Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nemours Children's Clinic — Jacksonville, Florida, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Dallas Otolaryngology Associates — Dallas, Texas, United States
- Callier Center — Dallas, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Eastern Virginia Medical School — Norfolk, Virginia, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- London Health Sciences Centre — London, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.