Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.

Med-El Corporation9 sites in 2 countries37 target enrollmentMarch 2004

ConditionsHearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Med-El Corporation
Enrollment: 37
Locations: 9
Primary Endpoint: Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

February 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Med-El Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

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
•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

Outcomes

Primary Outcomes

Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems

Time Frame: 60 months post initial stimulation

Speech perception scores will be compared pre-operatively and postoperatively.

Secondary Outcomes

Language Acquisition Over Time in Bilaterally Implanted Children.(60 months post initial activation)
Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.(5 years)