Hearing LossNCT03126825
CLEAR Clinical Study
A study testing CP910/CP920 with noise reduction on and CP910/CP920 in people with Hearing Loss, run by Cochlear at 2 sites in Australia.
Trial summary
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- CP910/CP920 with noise reduction on and CP910/CP920
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 May 2017to 1 Sep 2017
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
- Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
- At least three months CI experience in ear to be assessed
- At least three months experience with the CP810,CP920 or CP910 sound processor
- Fluent speaker in the local language used to assess clinical performance
- Open-set speech perception ability
- Use of or eligibility for hybrid acoustic component (hybrid population only)
Who cannot join
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
- Unwillingness or inability of the candidate to comply with all investigational requirements
- Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Cochlear Limited Melbourne
Melbourne, Victoria, 3002
Cochlear Limited Sydney
Sydney, New South Wales, 2109
About this study
Official title: Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.
- Conditions
- Hearing Loss
- Being tested
- CP910/CP920 with noise reduction on, CP910/CP920
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP910/CP920 with noise reduction onDevice
This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
CP910/CP920Device
The approved CP910 or CP920 Sound Processor.
| Study group | Role | What they receive |
|---|---|---|
| Conventional CI | Other | The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. Receives: Device: CP910/CP920 with noise reduction on; Device: CP910/CP920 |
| Hybrid CI | Other | The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. Receives: Device: CP910/CP920 with noise reduction on; Device: CP910/CP920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNC words
CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Measured: 3 months
SRT sentences
SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 May 2017
- Primary completion13 Aug 2017
- Study completion1 Sep 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Beth Brinson, Phd, Study director, Head of Global Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126825
- Sponsor's protocol ID
- CLTD5606
- Status last verified
- Jan 2018
- First submitted
- 20 Apr 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plan to make IPD available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
- ClinicalTrials.gov ID
- NCT03126825
- Acronym / sponsor ID
- CLTD5606
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 13 Aug 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional CI | Other | Device: CP910/CP920 with noise reduction on, Device: CP910/CP920The conventional CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. |
| Hybrid CI | Other | Device: CP910/CP920 with noise reduction on, Device: CP910/CP920The Hybrid CI group will receive the noise reduction on and off signal processing test programs. This is a within subject repeated measures design, so all subjects will receive the same testing but in a counterbalanced order. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
- Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
- At least three months CI experience in ear to be assessed
- At least three months experience with the CP810,CP920 or CP910 sound processor
- Fluent speaker in the local language used to assess clinical performance
Key exclusion criteria (3 listed)
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
- Unwillingness or inability of the candidate to comply with all investigational requirements
- Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.
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 |
|---|---|---|
| CP910/CP920 with noise reduction onThis intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm. | Device | Conventional CI, Hybrid CI |
| CP910/CP920The approved CP910 or CP920 Sound Processor. | Device | Conventional CI, Hybrid CI |
Primary outcome
CNC words
Time frame: 3 months
CNC words in quiet will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
SRT sentences
Time frame: 3 months
SRT sentences in noise will be used to assess whether the investigational noise reduction algorithm performs no worse than the approved Nucleus 6 defaults.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No. Currently no plan to make IPD available to other researchers.
Related trials for Hearing Loss
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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 Beth Brinson, Phd study director
Head of Global Clinical Affairs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP910/CP920 with noise reduction on and CP910/CP920 in people with Hearing Loss, run by Cochlear at 2 sites in Australia.
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 3 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 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CNC words (time frame: 3 months). 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 17 Jan 2018; AzTrials last refreshed its copy on 26 Oct 2026.