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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00784043
• Other study ID #: MED-EL NA 013
• Status: Terminated
• Phase: N/A
• Start date: March 2004
• Est. completion date: February 2017

Study information

• Verified date: April 2018
• Source: Med-El Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: February 2017
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Cochlear Implant
Bilateral Implantation in children

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Callier Center	Dallas	Texas
United States	Dallas Otolaryngology Associates	Dallas	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

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* Note: There are 72 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	60 months post initial stimulation
Secondary	Language Acquisition Over Time in Bilaterally Implanted Children.	Scores over time on the MacArthur communicative development inventory.	60 months post initial activation
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.	5 years