ImplantNCT01066780
ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users
A study testing ClearVoice in people with Implant, run by Advanced Bionics at 11 sites in 2 countries.
Trial summary
The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implant
- What is being tested?
- ClearVoice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2010to Sep 2010
- 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
- Post-lingually deafened,
- experienced (6 months device use),
- adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
- English language proficiency
Who cannot join
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States9 sites
The Johns Hopkins University
Baltimore, Maryland, 21205
Medical University of South Carolina
Charleston, South Carolina, 29425
Midwest Ear Institute
Kansas City, Missouri, 64111
University of Kentucky
Lexington, Kentucky, 40506-9983
House Ear Clinic
Los Angeles, California, 90057
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mayo Clinic
Rochester, Minnesota, 55905
Washington University Medical Center
St Louis, Missouri, 63110
Carle Clinic Association
Urbana, Illinois, 61801
Canada2 sites
Nova Scotia Hearing and Speech Centres
Halifax, Nova Scotia, B3J 3R4
Sunnybrook Health Sciences Centre
Toronto, M4N 3M5
About this study
Official title: Evaluation of the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing
The purpose of this study is to collect information about how the new sound-processing affects the ability to hear in everyday listening situations.
- Conditions
- Implant
- Being tested
- ClearVoice
- 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.
ClearVoiceDevice
ClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®)
| Study group | Role | What they receive |
|---|---|---|
| Group A: ClearVoice Medium | Experimental | Chronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks. Receives: Device: ClearVoice |
| Group B: ClearVoice High | Experimental | Chronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks. Receives: Device: ClearVoice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise
This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.
Measured: 4 Weeks
Secondary outcomes (1)
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
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 ImplantStudies 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
- 48 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
- NCT01066780
- Sponsor's protocol ID
- CR0309
- Status last verified
- Oct 2012
- First submitted
- 9 Feb 2010
- 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 the ClearVoice™ Strategy in Adults Using HiResolution® Fidelity 120® Sound Processing
- ClinicalTrials.gov ID
- NCT01066780
- Acronym / sponsor ID
- CR0309
- Conditions
- Implant
- Keywords
- cochlear implant, adults, HiResolution, Fidelity 120, listening benefits, noise, cochlear implant benefit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Posted 25 Oct 2012
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 collect information about how the new sound-processing affects the ability to hear in everyday listening situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ClearVoice Medium | Experimental | Device: ClearVoiceChronic use of ClearVoice MEDIUM for two weeks followed by chronic use of ClearVoice HIGH for two weeks. |
| Group B: ClearVoice High | Experimental | Device: ClearVoiceChronic use of ClearVoice HIGH for two weeks followed by chronic use of ClearVoice MEDIUM for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-lingually deafened,
- experienced (6 months device use),
- adult users of the Harmony HiResolution Bionic Ear System and HiRes Fidelity 120 sound processing.
- English language proficiency
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ClearVoiceClearVoice is a sound processing strategy designed to improve listening ability in some challenging everyday listening environments for users of the Harmony® HiResolution® Bionic Ear System (Harmony®) | Device | Group A: ClearVoice Medium, Group B: ClearVoice High |
Primary outcome
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise
Time frame: 4 Weeks
This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.
1 secondary outcome
The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.
Time frame: 2-4 weeks
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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearVoice in people with Implant, run by Advanced Bionics at 11 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 4 inclusion and 0 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 11 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 Oct 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?
Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise (time frame: 4 Weeks). 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; AzTrials last refreshed its copy on 1 Nov 2026.