Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant

MED-EL

Status

Terminated

Conditions

Hearing Loss

Treatments

Device: Cochlear Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00784043

MED-EL NA 013

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

12 to 36 months old

Volunteers

No Healthy Volunteers

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.
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 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

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