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

A study testing Cochlear Implant in people with Hearing Loss, run by Med-El Corporation at 9 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 12 to 36 months
Conditions the study is for: Hearing Loss
What is being tested?: Cochlear Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 9 sitesin 2 countries
Study dates: Mar 2004to Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 36 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Show all 15Show fewer

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

Who cannot join

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

Show all 10Show fewer

Severed or non-functional auditory nerve in the ear(s) to be implanted
Central auditory lesion
Cognitive and/or neurological dysfunction
Auditory neuropathy

Trial locations and contacts

9 sites in 2 countries.

Country

City, postcode or hospital

9 sites in 2 countries

United States8 sites

Children's Healthcare of Atlanta
Atlanta, Georgia, 30324
Cleveland Clinic Foundation
Cleveland, Ohio, 44124
Dallas Otolaryngology Associates
Dallas, Texas, 75230
Callier Center
Dallas, Texas, 75235
Texas Children's Hospital
Houston, Texas, 77030
Nemours Children's Clinic
Jacksonville, Florida, 32207
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Eastern Virginia Medical School
Norfolk, Virginia, 23507

Other trials in United States

Canada1 site

London Health Sciences Centre
London, Ontario, N6A 5A5

Other trials in Canada

About this study

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

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
Being tested: Cochlear Implant
Keywords: Cochlear implant, hearing loss
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cochlear ImplantDevice
Also called MED-EL Cochlear Implant, Combi 40+, PulsarCI100, SonataTI100
Bilateral Implantation in children

Study groups in NCT00784043
Study group	Role	What they receive
Bilateral	Experimental	Bilaterally implanted simultaneously Receives: Device: Cochlear Implant
Unilateral	Experimental	Unilaterally implanted Receives: Device: Cochlear Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 60 months post initial stimulation

Secondary outcomes (2)

Language Acquisition Over Time in Bilaterally Implanted Children.
Scores over time on the MacArthur communicative development inventory.
Measured: 60 months post initial activation
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Feb 2017

First posted3 Nov 2008 (estimated)
Study startMar 2004
Primary completionSep 2009
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (72)Papers the sponsor has linked to this study.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784043
Sponsor's protocol ID: MED-EL NA 013
Status last verified: Apr 2018
First submitted: 30 Oct 2008
Last updated: 25 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 15364496
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.
PubMed 15179112
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.
PubMed 15179111
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.
PubMed 12072612
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.
PubMed 12218624
Tyler RS, Gantz BJ, Rubinstein JT, Wilson BS, Parkinson AJ, Wolaver A, Preece JP, Witt S, Lowder MW. Three-month results with bilateral cochlear implants. Ear Hear. 2002 Feb;23(1 Suppl):80S-89S. doi: 10.1097/00003446-200202001-00010.
PubMed 11883771
Winkler F, Schon F, Peklo L, Muller J, Feinen Ch, Helms J. [The Wurzburg questionnaire for assessing the quality of hearing in CI-children (WH-CIK)]. Laryngorhinootologie. 2002 Mar;81(3):211-6. doi: 10.1055/s-2002-25042. German.
PubMed 11967774
Zimmerman-Phillips S, Robbins AM, Osberger MJ. Assessing cochlear implant benefit in very young children. Ann Otol Rhinol Laryngol Suppl. 2000 Dec;185:42-3. doi: 10.1177/0003489400109s1217. No abstract available.
PubMed 11140998
Kirk KI, Pisoni DB, Osberger MJ. Lexical effects on spoken word recognition by pediatric cochlear implant users. Ear Hear. 1995 Oct;16(5):470-81. doi: 10.1097/00003446-199510000-00004.
PubMed 8654902
Grantham DW, Ashmead DH, Ricketts TA, Labadie RF, Haynes DS. Horizontal-plane localization of noise and speech signals by postlingually deafened adults fitted with bilateral cochlear implants. Ear Hear. 2007 Aug;28(4):524-41. doi: 10.1097/AUD.0b013e31806dc21a.
PubMed 17609614
Ricketts TA, Grantham DW, Ashmead DH, Haynes DS, Labadie RF. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear. 2006 Dec;27(6):763-73. doi: 10.1097/01.aud.0000240814.27151.b9.
PubMed 17086085
Dorman MF, Dahlstrom L. Speech understanding by cochlear-implant patients with different left- and right-ear electrode arrays. Ear Hear. 2004 Apr;25(2):191-4. doi: 10.1097/01.aud.0000120367.70123.9a.
PubMed 15064664
Laback B, Pok SM, Baumgartner WD, Deutsch WA, Schmid K. Sensitivity to interaural level and envelope time differences of two bilateral cochlear implant listeners using clinical sound processors. Ear Hear. 2004 Oct;25(5):488-500. doi: 10.1097/01.aud.0000145124.85517.e8.
PubMed 15599195
Van Hoesel R, Ramsden R, Odriscoll M. Sound-direction identification, interaural time delay discrimination, and speech intelligibility advantages in noise for a bilateral cochlear implant user. Ear Hear. 2002 Apr;23(2):137-49. doi: 10.1097/00003446-200204000-00006.
PubMed 11951849
Pijl S. Single-channel versus bilateral multichannel cochlear implant results: a case report. Ear Hear. 1991 Dec;12(6):431-3. doi: 10.1097/00003446-199112000-00007.
PubMed 1797610

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems.
ClinicalTrials.gov ID: NCT00784043
Acronym / sponsor ID: MED-EL NA 013
Conditions: Hearing Loss
Keywords: Cochlear implant, hearing loss
Study type: Interventional
Recruitment status: Terminated
Enrolment: 37 participants (actual)
Lead sponsor: Med-El CorporationIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: Sep 2009 (actual)
Study completion: Feb 2017 (actual)
First posted: 3 Nov 2008 (estimated)
Results: Posted 25 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bilateral	Experimental	Device: Cochlear ImplantBilaterally implanted simultaneously
Unilateral	Experimental	Device: Cochlear ImplantUnilaterally implanted

Who may qualify

Ages: 12 to 36 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (15 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cochlear ImplantAlso: MED-EL Cochlear Implant, Combi 40+, PulsarCI100, SonataTI100Bilateral Implantation in children	Device	Bilateral, Unilateral

Primary outcome

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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 25 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bilateral	31	0
Unilateral	6	0

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

Time frame: 60 months post initial stimulation

Population analysed: Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of enrollment through the study endpoint ( 5 years postoperatively) for each subject. However, due to early termination of the study the endpoint was not reached, and participants were followed for an average of 3 years postoperatively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bilateral	6 of 31 (19.4%)	4 of 31 (12.9%)	0 of 31
Unilateral	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Protocol was terminated due to inability to find unilateral matches.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15364496Kuhn-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.
Background: PubMed 15179112Nopp 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.
Background: PubMed 15179111Schleich 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.
Background: PubMed 12072612Muller 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.
Background: PubMed 12218624Schon 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.
Background: PubMed 11883771Tyler RS, Gantz BJ, Rubinstein JT, Wilson BS, Parkinson AJ, Wolaver A, Preece JP, Witt S, Lowder MW. Three-month results with bilateral cochlear implants. Ear Hear. 2002 Feb;23(1 Suppl):80S-89S. doi: 10.1097/00003446-200202001-00010.
Background: PubMed 11967774Winkler F, Schon F, Peklo L, Muller J, Feinen Ch, Helms J. [The Wurzburg questionnaire for assessing the quality of hearing in CI-children (WH-CIK)]. Laryngorhinootologie. 2002 Mar;81(3):211-6. doi: 10.1055/s-2002-25042. German.
Background: PubMed 11140998Zimmerman-Phillips S, Robbins AM, Osberger MJ. Assessing cochlear implant benefit in very young children. Ann Otol Rhinol Laryngol Suppl. 2000 Dec;185:42-3. doi: 10.1177/0003489400109s1217. No abstract available.
Background: PubMed 8654902Kirk KI, Pisoni DB, Osberger MJ. Lexical effects on spoken word recognition by pediatric cochlear implant users. Ear Hear. 1995 Oct;16(5):470-81. doi: 10.1097/00003446-199510000-00004.
Background: PubMed 17609614Grantham DW, Ashmead DH, Ricketts TA, Labadie RF, Haynes DS. Horizontal-plane localization of noise and speech signals by postlingually deafened adults fitted with bilateral cochlear implants. Ear Hear. 2007 Aug;28(4):524-41. doi: 10.1097/AUD.0b013e31806dc21a.
Background: PubMed 17086085Ricketts TA, Grantham DW, Ashmead DH, Haynes DS, Labadie RF. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear. 2006 Dec;27(6):763-73. doi: 10.1097/01.aud.0000240814.27151.b9.
Background: PubMed 15064664Dorman MF, Dahlstrom L. Speech understanding by cochlear-implant patients with different left- and right-ear electrode arrays. Ear Hear. 2004 Apr;25(2):191-4. doi: 10.1097/01.aud.0000120367.70123.9a.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Implant in people with Hearing Loss, run by Med-El Corporation at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems (time frame: 60 months post initial stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784043, which also lists 72 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.