Severe to Profound Hearing LossNCT01616576
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
A study of Severe to Profound Hearing Loss and in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System, run by Advanced Bionics at 5 sites in United States.
Trial summary
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2012to Sep 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
- 18 years of age or older at time of implant
- Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
- At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
- English language proficiency
- Willingness to use a Harmony™ BTE processor and refrain from ClearVoice™ use for the duration of the study
- Willingness and ability to participate in all scheduled procedures outlined in the protocol
Who cannot join
- Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Midwest Ear Institute (MEI)
Kansas City, Missouri, 64111
House Ear Clinic
Los Angeles, California, 90057
Washington University
St Louis, Missouri, 63110
Tampa Bay Hearing and Balance
Tampa, Florida, 33606
Carle Clinic Association
Urbana, Illinois, 61801
About this study
The purpose of this study is to compare a new sound processing strategy to the current sound processing strategy.
- Conditions
- Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
- Being tested
- Control first, then Experimental, Experimental first, then Control
- Keywords
- cochlear implant, adults, HiResolution™, Fidelity 120™, listening benefits, noise, cochlear implant benefit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control first, then ExperimentalDevice
Control condition is currently marketed sound processing strategy.
Experimental first, then ControlDevice
Experimental condition is newly modified sound processing strategy.
| Study group | Role | What they receive |
|---|---|---|
| Control first, then Experimental (Group A) | Experimental | Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. Receives: Device: Control first, then Experimental |
| Experimental first, then Control (Group B) | Experimental | Initial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week. Receives: Device: Experimental first, then Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Measured: 2 weeks
Device-related Adverse Events
Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
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 Severe to Profound 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616576
- Sponsor's protocol ID
- CR0611
- Status last verified
- Aug 2014
- First submitted
- 1 Jun 2012
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
- ClinicalTrials.gov ID
- NCT01616576
- Acronym / sponsor ID
- CR0611
- Conditions
- Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
- Keywords
- cochlear implant, adults, HiResolution™, Fidelity 120™, listening benefits, noise, cochlear implant benefit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 15 Aug 2014
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 compare a new sound processing strategy to the current sound processing strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control first, then Experimental (Group A) | Experimental | Device: Control first, then ExperimentalInitial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week. |
| Experimental first, then Control (Group B) | Experimental | Device: Experimental first, then ControlInitial subject use of Experimental (HiRes™ Optima) Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral or bilateral user of CII/HiRes90K™ implant(s) (minimum of one year in each implanted ear), Harmony™ BTE processor(s) with HiRes Fidelity 120™ (with or without ClearVoice™) as preferred sound processing strategy
- 18 years of age or older at time of implant
- Postlingual onset of severe-to-profound hearing loss (≥ 6 years of age)
- At least moderate open-set speech recognition abilities (defined as CNC word score ≥ 50% in medical records or assessed at the Baseline Visit with implant alone for unilateral users, with both implants together for bilateral users)
- English language proficiency
Key exclusion criteria (1 listed)
- Presence of any additional disabilities that would prevent or interfere with participation in the required speech perception testing
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 |
|---|---|---|
| Control first, then ExperimentalControl condition is currently marketed sound processing strategy. | Device | Control first, then Experimental (Group A) |
| Experimental first, then ControlExperimental condition is newly modified sound processing strategy. | Device | Experimental first, then Control (Group B) |
Primary outcome
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.
Time frame: 2 weeks
Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.
Device-related Adverse Events
Time frame: 2 weeks
Device-related adverse events will be assessed to determine whether they impact current device safety performance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Severe to Profound Hearing Loss and in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System, run by Advanced Bionics at 5 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). 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?
Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise. (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 22 Jul 2020.