Status:
UNKNOWN
Outcomes of Cochlear Implantation in Pediatrics
Lead Sponsor:
Amira Mohmed Ahmed Bakr
Collaborating Sponsors:
Assiut University
Conditions:
Hearing Impaired Children
Eligibility:
All Genders
2+ years
Brief Summary
The cochlear implant (CI) is the most important progress in the treatment for adults and children with severe to profound bilateral sensorineural hearing loss who do not receive adequa¬te benefit from...
Detailed Description
Tomblin JB et al.1997, Svirsky MA, 2004 reported that the early restoration of auditory ability by cochlear implants significantly improve the commu¬nication skills, albeit with varied results. Thoute...
Eligibility Criteria
Inclusion
- Between 2 and 5 years of age at time of implantation
- Profound bilateral sensorineural hearing loss
- Arabic 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
- Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and aboveBehavioral 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.
Exclusion
- Subjects with mental retardation (MR), below average mentality or any subject with behavioral problems, traumatic brain injury, additional significant disabilities (e.g., blindness, autism) or with auditory neuropathy were excluded from the study
- \-
Key Trial Info
Start Date :
May 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04092231
Start Date
May 1 2020
End Date
December 30 2022
Last Update
February 25 2020
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