Hearing LossNCT02934373
Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
A study testing A New Sound Processor in people with Hearing Loss, run by Cochlear at 3 sites in 2 countries.
Trial summary
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System Read more about this study
- Who is it for?
- Ages 1 year to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- A New Sound Processor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Start not givento Nov 2016
- 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 1 year to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 12 months old or older
- Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
- Use of the CP810, CP920 or CP910 sound processor
- Willingness to participate in and to comply with all requirements of the protocol
Who cannot join
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
- Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
- Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Nottingham University Hospitals - Queens Medical Centre
Nottingham, Nottinghamshire, NG5 1PB
University of Southampton - Auditory Implant Service Highfield
Southampton, Hampshire, SO17 1BJ
About this study
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System
- Conditions
- Hearing Loss
- Being tested
- A New Sound Processor
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A New Sound ProcessorDevice
| Study group | Role | What they receive |
|---|---|---|
| A New Sound Processor | Active comparator | Sound Processor is the next generation sound processor. Receives: Device: A New Sound Processor |
| Subject's own sound processor | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective rating with a new sound processor compared to ratings with each subjects own processor
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 posted17 Oct 2016 (estimated)
- Primary completionNov 2016
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.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Beth Brinson, Study chair, Head of Clinical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934373
- Sponsor's protocol ID
- CLTD5665
- Status last verified
- Nov 2016
- First submitted
- 13 Oct 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Subjective Ratings on a New Sound Processor and Compatible Products
- ClinicalTrials.gov ID
- NCT02934373
- Acronym / sponsor ID
- CLTD5665
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Primary completion
- Nov 2016 (actual)
- First posted
- 17 Oct 2016 (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.
Clinical study designed to collect user feedback from Cochlear Implant recipients on a new Sound Processor System
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A New Sound Processor | Active comparator | Device: A New Sound ProcessorSound Processor is the next generation sound processor. |
| Subject's own sound processor | No intervention | – |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 12 months old or older
- Implanted with a CI24RE (Freedom implant) or later implant in at least one implanted ear
- Use of the CP810, CP920 or CP910 sound processor
- Willingness to participate in and to comply with all requirements of the protocol
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 procedure and prosthetic device
- Additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected
- Nucleus 22 or Nucleus 24 Implant in ear to be fitted with the investigational device
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 |
|---|---|---|
| A New Sound Processor | Device | A New Sound Processor |
Primary outcome
Subjective rating with a new sound processor compared to ratings with each subjects own processor
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Individual participant dataSharing planned: No
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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 Beth Brinson study chair
Head of Clinical Affairs
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A New Sound Processor in people with Hearing Loss, run by Cochlear at 3 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 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: withdrawn, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Subjective rating with a new sound processor compared to ratings with each subjects own processor (time frame: 3 months). 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 Nov 2016.