Hearing LossNCT02309541
Evaluation of New Feedback Canceller for Carina™ Implant
A study testing feedback canceller algorithm (Firmware) in people with Hearing Loss, run by Cochlear at 3 sites in France.
Trial summary
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss
- What is being tested?
- feedback canceller algorithm (Firmware)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2015to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
- native speaker in the language used to assess their clinical performance, i.e. French
Who cannot join
- unwillingness or inability to comply with all of the investigational requirements
- additional handicaps that would prevent or restrict participation in the audiological evaluations
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Edouard Herriot
Lyon, Rhône, 69003
Hôpital Nord
Marseille, Bouches-du-Rhône, 13915
CHU Lyon Sud
Pierre-Bénite, Rhône, 69495
About this study
Official title: Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.
- Conditions
- Hearing Loss
- Being tested
- feedback canceller algorithm (Firmware)
- Keywords
- middle ear implant, feedback manager, Sound quality
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feedback canceller algorithm (Firmware)Device
The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Firmware N | Experimental | New feedback canceller algorithm Receives: Device: feedback canceller algorithm (Firmware) |
| Firmware R | Active comparator | Current feedback canceller algorithm (reference) Receives: Device: feedback canceller algorithm (Firmware) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Measured: 1 month
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Measured: 2 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Measured: 3 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Measured: 4 months
Secondary outcomes (4)
Improvement in speech understanding assessed via speech audiometry in noise
Measured: 1 month
Improvement in speech understanding assessed via speech audiometry in noise
Measured: 2 months
Improvement in speech understanding assessed via speech audiometry in noise
Measured: 3 months
Improvement in speech understanding assessed via speech audiometry in noise
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionSep 2017
- Study completionSep 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stéphane Tringali, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309541
- Sponsor's protocol ID
- CFRA-A01/CEL5584
- Status last verified
- Oct 2017
- First submitted
- 2 Dec 2014
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Feedback Canceller Algorithm for Patient With Moderate to Severe Hearing Loss Implanted With a Fully Implantable Carina™ Medical Device
- ClinicalTrials.gov ID
- NCT02309541
- Acronym / sponsor ID
- CFRA-A01/CEL5584
- Conditions
- Hearing Loss
- Keywords
- middle ear implant, feedback manager, Sound quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Dec 2014 (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.
The purpose of this study is to evaluate audio quality benefit for the patient implanted with a Cochlear or Otologics Carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). The new firmware aims to adapt automatically for feedback cancellation without prior calibration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firmware N | Experimental | Device: feedback canceller algorithm (Firmware)New feedback canceller algorithm |
| Firmware R | Active comparator | Device: feedback canceller algorithm (Firmware)Current feedback canceller algorithm (reference) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- successfully implanted with a commercial available CE-labelled implant device, resulting in measurable open set speech understanding
- native speaker in the language used to assess their clinical performance, i.e. French
Key exclusion criteria (2 listed)
- unwillingness or inability to comply with all of the investigational requirements
- additional handicaps that would prevent or restrict participation in the audiological evaluations
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 |
|---|---|---|
| feedback canceller algorithm (Firmware)The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms. | Device | Firmware N, Firmware R |
Primary outcome
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time frame: 1 month
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time frame: 2 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time frame: 3 months
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire
Time frame: 4 months
4 secondary outcomes
Improvement in speech understanding assessed via speech audiometry in noise
Time frame: 1 month
Improvement in speech understanding assessed via speech audiometry in noise
Time frame: 2 months
Improvement in speech understanding assessed via speech audiometry in noise
Time frame: 3 months
Improvement in speech understanding assessed via speech audiometry in noise
Time frame: 4 months
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 9 Oct 2017.
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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.
Stéphane Tringali, Prof principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing feedback canceller algorithm (Firmware) in people with Hearing Loss, run by Cochlear at 3 sites in France.
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 2 inclusion and 2 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 9 Oct 2017. 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 France. 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?
Sound quality benefit assessed via subjective patient evaluation with Abbreviated Profile of Hearing Aid Benefit questionnaire (time frame: 1 month). The study lists 4 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 9 Oct 2017.