Hearing LossPhase 4NCT00205881
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
A Phase 4 study testing HiRes 90K Bionic Ear System in people with Hearing Loss, run by Advanced Bionics at 9 sites in United States.
Trial summary
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- HiRes 90K Bionic Ear System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2004to May 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No previous implant experience.
- Age 18 years or older.
- Postlingual onset of hearing loss.
- Sensorineural hearing loss of a severe or greater degree in both ears.
- Normal/patent cochlear anatomy in each ear.
- English language proficiency.
- Willingness and ability to participate in all scheduled procedures.
Who cannot join
- No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Dallas Otolaryngology Associates
Dallas, Texas, 75230
Spectrum Health
Grand Rapids, Michigan, 49546
Midwest Ear Institute
Kansas City, Missouri, 64108
House Clinic/House Ear Institute
Los Angeles, California, 90057
University of Miami - Cochlear Implant Center
Miami, Florida, 33136
New York University Cochlear Implant Center
New York, New York, 10016
California Ear Institute (Let Them Hear Foundation)
Palo Alto, California, 94303
Tampa Bay Hearing and Balance Center
Tampa, Florida, 33606
Carle Clinic Association
Urbana, Illinois, 61801
About this study
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
- Conditions
- Hearing Loss
- Being tested
- HiRes 90K Bionic Ear System
- Keywords
- HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiRes 90K Bionic Ear SystemDevice
Cochlear implant system
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bilaterally Implanted with HiRes 90K device. Receives: Device: HiRes 90K Bionic Ear System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
Measured: 8 months of bilateral cochlear implant use
Secondary outcomes (1)
HINT Sentences in Noise
20 sentences presented in noise at fixed levels
Measured: 8 months of bilateral cochlear implant use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Joe Osberger, Study chair, Advanced Bionics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205881
- Sponsor's protocol ID
- AUD-BL-070705
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 1 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System
- ClinicalTrials.gov ID
- NCT00205881
- Acronym / sponsor ID
- AUD-BL-070705
- Conditions
- Hearing Loss
- Keywords
- HiResolution Bionic Ear, severe to profound hearing loss, bilateral implantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 10 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: HiRes 90K Bionic Ear SystemBilaterally Implanted with HiRes 90K device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No previous implant experience.
- Age 18 years or older.
- Postlingual onset of hearing loss.
- Sensorineural hearing loss of a severe or greater degree in both ears.
- Normal/patent cochlear anatomy in each ear.
Key exclusion criteria (1 listed)
- No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
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 |
|---|---|---|
| HiRes 90K Bionic Ear SystemCochlear implant system | Device | 1 |
Primary outcome
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users.
Time frame: 8 months of bilateral cochlear implant use
Participants were tested on 50 monosyllabic, phonetically balanced words from the Consonant-Nucleus-Consonant (CNC) set, prior to implantation and after bilateral implantation. Percent correct scores for the CNC test are reported.
1 secondary outcome
HINT Sentences in Noise
Time frame: 8 months of bilateral cochlear implant use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 study chair
Advanced Bionics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HiRes 90K Bionic Ear System in people with Hearing Loss, run by Advanced Bionics at 9 sites in United States.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2012. 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. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2012). 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?
Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. (time frame: 8 months of bilateral cochlear implant use). 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 1 Mar 2012.