Hearing LossPhase 4NCT00424307
Bilateral Cochlear Implant Benefit in Young Children
A Phase 4 study testing HiResolution Bionic Ear System in people with Hearing Loss, run by Advanced Bionics at 14 sites in 2 countries.
Trial summary
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than… 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?
- HiResolution Bionic Ear System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2007to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Profound bilateral hearing loss
- Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
- Age at implant: 12-36 months
- No previous cochlear implant use
- English as the primary language spoken in the home
- Parental willingness to follow study protocol
Who cannot join
- Deafness secondary to meningitis
- Presence of other conditions that could affect study participation
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Children's HEAR Center
Birmingham, Alabama, 35233
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
The Children's Memorial Hospital
Chicago, Illinois, 60614
Dallas Otolaryngology Associates
Dallas, Texas, 75230
Spectrum Health Hospital
Grand Rapids, Michigan, 49546
Midwest Ear Institute
Kansas City, Missouri, 64111
House Ear Institute
Los Angeles, California, 90057
New York University
New York, New York, 10016
Boys Town National Research Hospital
Omaha, Nebraska, 68131
University of California, San Francisco
San Francisco, California, 94143
Washington University of St. Louis
St Louis, Missouri, 63110
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606
Carle Foundation Hospital
Urbana, Illinois, 61801
About this study
Official title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.
- Conditions
- Hearing Loss
- Being tested
- HiResolution Bionic Ear System
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiResolution Bionic Ear SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Speech Perception Skills
Measured: Various time points
Secondary outcomes (1)
Health-Related Quality of Life and Assessment of Communicative Performance
Measured: Various time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary Joe Osberger, Ph.D., Study chair, Advanced Bionics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424307
- Sponsor's protocol ID
- ACR0906
- Status last verified
- Jun 2011
- First submitted
- 17 Jan 2007
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
- ClinicalTrials.gov ID
- NCT00424307
- Acronym / sponsor ID
- ACR0906
- Conditions
- Hearing Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 19 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Profound bilateral hearing loss
- Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
- Age at implant: 12-36 months
- No previous cochlear implant use
- English as the primary language spoken in the home
Key exclusion criteria (2 listed)
- Deafness secondary to meningitis
- Presence of other conditions that could affect study participation
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 |
|---|---|---|
| HiResolution Bionic Ear System | Device | – |
Primary outcome
Assessment of Speech Perception Skills
Time frame: Various time points
1 secondary outcome
Health-Related Quality of Life and Assessment of Communicative Performance
Time frame: Various time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Mary Joe Osberger, Ph.D. study chair
Advanced Bionics
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HiResolution Bionic Ear System in people with Hearing Loss, run by Advanced Bionics at 14 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Assessment of Speech Perception Skills (time frame: Various time points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2011.