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

NCT00784043 | Terminated Results

• 1 other identifier: MED-EL NA 013
• Study Type: interventional
• Target: 37
• Locations: 2 countries
• Sites: 9

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.

Conditions

Hearing Loss

Keywords

Cochlear implant; hearing loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Bilateral

EXPERIMENTAL

Bilaterally implanted simultaneously

Device: Cochlear Implant

Unilateral

EXPERIMENTAL

Unilaterally implanted

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

Bilateral Implantation in children

Also known as: MED-EL Cochlear Implant, Combi 40+, PulsarCI100, SonataTI100

Bilateral; Unilateral

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (9)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30324, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44124, United States

Location

Dallas Otolaryngology Associates

Dallas, Texas, 75230, United States

Location

Callier Center

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (72)

• Kuhn-Inacker H, Shehata-Dieler W, Muller J, Helms J. Bilateral cochlear implants: a way to optimize auditory perception abilities in deaf children? Int J Pediatr Otorhinolaryngol. 2004 Oct;68(10):1257-66. doi: 10.1016/j.ijporl.2004.04.029.

  PMID: 15364496 BACKGROUND

• Nopp P, Schleich P, D'Haese P. Sound localization in bilateral users of MED-EL COMBI 40/40+ cochlear implants. Ear Hear. 2004 Jun;25(3):205-14. doi: 10.1097/01.aud.0000130793.20444.50.

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• Schleich P, Nopp P, D'Haese P. Head shadow, squelch, and summation effects in bilateral users of the MED-EL COMBI 40/40+ cochlear implant. Ear Hear. 2004 Jun;25(3):197-204. doi: 10.1097/01.aud.0000130792.43315.97.

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• Muller J, Schon F, Helms J. Speech understanding in quiet and noise in bilateral users of the MED-EL COMBI 40/40+ cochlear implant system. Ear Hear. 2002 Jun;23(3):198-206. doi: 10.1097/00003446-200206000-00004.

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• Schon F, Muller J, Helms J. Speech reception thresholds obtained in a symmetrical four-loudspeaker arrangement from bilateral users of MED-EL cochlear implants. Otol Neurotol. 2002 Sep;23(5):710-4. doi: 10.1097/00129492-200209000-00018.

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MeSH Terms

Conditions

Hearing Loss

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Limitations and Caveats

Protocol was terminated due to inability to find unilateral matches.

Results Point of Contact

• Title: Jennifer Bulls
• Organization: MED-EL Corporation

research.us@medel.com

1-888-633-3524

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: November 3, 2008
• Study Start: March 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2017
• Last Updated: May 25, 2018
• Results First Posted: May 25, 2018

Record last verified: 2018-04

Locations

CA (1); US (8)