Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
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.
Study Design
Allocation: Non-Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Hearing Loss
Intervention
Cochlear Implant
Location
Nemours Children's Clinic
Jacksonville
Florida
United States
32207
Status
Enrolling by invitation
Source
Med-El Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00784043
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hearing Loss, Central
Hearing loss due to disease of the AUDITORY PATHWAYS (in the CENTRAL NERVOUS SYSTEM) which originate in the COCHLEAR NUCLEI of the PONS and then ascend bilaterally to the MIDBRAIN, the THALAMUS, and then the AUDITORY CORTEX in the TEMPORAL LOBE. Bilateral lesions of the auditory pathways are usually required to cause central hearing loss. Cortical deafness refers to loss of hearing due to bilateral auditory cortex lesions. Unilateral BRAIN STEM lesions involving the cochlear nuclei may result in unilateral hearing loss.
Presbycusis
Gradual bilateral hearing loss associated with aging that is due to progressive degeneration of cochlear structures and central auditory pathways. Hearing loss usually begins with the high frequencies then progresses to sounds of middle and low frequencies.
Cochlear Nerve
The cochlear part of the 8th cranial nerve (VESTIBULOCOCHLEAR NERVE). The cochlear nerve fibers originate from neurons of the SPIRAL GANGLION and project peripherally to cochlear hair cells and centrally to the cochlear nuclei (COCHLEAR NUCLEUS) of the BRAIN STEM. They mediate the sense of hearing.
Cochlear Implantation
Surgical insertion of an electronic hearing device (COCHLEAR IMPLANTS) with electrodes to the COCHLEAR NERVE in the inner ear to create sound sensation in patients with residual nerve fibers.
Branchio-oto-renal Syndrome
An autosomal dominant disorder manifested by various combinations of preauricular pits, branchial fistulae or cysts, lacrimal duct stenosis, hearing loss, structural defects of the outer, middle, or inner ear, and renal dysplasia. Associated defects include asthenic habitus, long narrow facies, constricted palate, deep overbite, and myopia. Hearing loss may be due to Mondini type cochlear defect and stapes fixation. (Jablonski's Dictionary of Syndromes & Eponymic Diseases, 2d ed)
Clinical Trials
Relationship Between Auto NRT and Behavioural T & C Levels With the Nucleus Freedom Cochlear Implant
Cochlear implants require programming on an individual basis to provide appropriate levels of electrical stimulation. This program, or "map", is placed in the speech processor of the cochl...
Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study
The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in...
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive tw...
Scalar Localization Cochlear Electrode Array Using 64 Slice CT
Insertion of electrode array in scala vestibuli, rather than the preferred location within scala tympani, leads to loss of native hearing in those patients with isolated high-frequency hea...
Nucleus Freedom Cochlear Implant System Pediatric Post-Approval Study
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
PubMed Articles
Reduced visual discrimination in cochlear implant users.
The aim of the study was to investigate low-level visual function in cochlear implant users. Spatial frequency discrimination was assessed in 16 adults with normal hearing and 18 adults with profound...
Cross-Modal Plasticity and Speech Perception in Pre- and Postlingually Deaf Cochlear Implant Users.
OBJECTIVE:: A great amount of variability is observed in speech perception outcomes with cochlear implants. The mechanisms behind the observed variability need to be elucidated. One possible mechanism...
: The aim of this study was to develop guidelines, based on the unaided pure-tone audiogram, for recommending a cochlear implant (CI) for infants and young children with residual hearing. As awareness...
OBJECTIVE:: One of the most devastating sequelae of bacterial meningitis is profound hearing loss or even deafness. Although cochlear implantation is able to restore (some) hearing abilities, oblitera...
