Hearing Loss
Conditions
Keywords
Cochlear implant, hearing loss
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.
Interventions
DEVICECochlear Implant
Bilateral Implantation in children
Sponsors
Med-El Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems | 60 months post initial stimulation | Speech perception scores will be compared pre-operatively and postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Language Acquisition Over Time in Bilaterally Implanted Children. | 60 months post initial activation | Scores over time on the MacArthur communicative development inventory. |
| Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant. | 5 years | Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bilateral Bilaterally implanted simultaneously
Cochlear Implant: Bilateral Implantation in children | 31 |
| Unilateral Unilaterally implanted
Cochlear Implant: Bilateral Implantation in children | 6 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Terminated | 23 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 5 |
Baseline characteristics
| Characteristic | Bilateral | Unilateral | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 6 Participants | 37 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 5 participants | 0 participants | 5 participants |
| Region of Enrollment United States | 26 participants | 6 participants | 32 participants |
| Sex: Female, Male Female | 12 Participants | 0 Participants | 12 Participants |
| Sex: Female, Male Male | 16 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 6 |
| other Total, other adverse events | 4 / 31 | 0 / 6 |
| serious Total, serious adverse events | 6 / 31 | 0 / 6 |
Outcome results
Primary
Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems
Speech perception scores will be compared pre-operatively and postoperatively.
Time frame: 60 months post initial stimulation
Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here
Secondary
Language Acquisition Over Time in Bilaterally Implanted Children.
Scores over time on the MacArthur communicative development inventory.
Time frame: 60 months post initial activation
Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here
Secondary
Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.
Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.
Time frame: 5 years
Population: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here.