Hearing LossNCT02228148
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
A study testing NFS and CSS in people with Hearing Loss, run by Cochlear at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- NFS and CSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2014to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid)
- Post linguistically deafened adults (≥ 18 years)
- Unilaterally implanted
- ≤ 15 years of severe to profound deafness prior to implantation
- Subjects who are capable and willing to participate in speech perception tests in local language
- Subjects who are able to provide feedback in form of a written questionnaire (e.g. Speech Spatial Hearing Qualities questionnaire)
- Subjects willing to give their consent to the study
Who cannot join
- Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness)
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method
- Bilateral implantation
- Hybrid-L (not supported by Nucleus Fitting Software)
- Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant)
- Subjects with single-sided deafness
- Known cochlea malformations
- Subjects who lost their hearing due to meningitis
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
Kiel, Schleswig-Holstein, 24105
Switzerland1 site
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Zurich, Canton of Zurich, 8091
About this study
Official title: Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.
- Conditions
- Hearing Loss
- Being tested
- NFS, CSS
- Keywords
- Post linguistically deafness, severe to profound deafness
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFSDevice
Cochlear Nucleus Fitting Software
CSSDevice
Cochlear Nucleus Custom SoundTM Suite
| Study group | Role | What they receive |
|---|---|---|
| NFS | Experimental | Cochlear Nucleus Fitting Software Receives: Device: NFS |
| CSS | Active comparator | Cochlear Nucleus Custom SoundTM Suite Receives: Device: CSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Measured: 3 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Measured: 6 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Measured: 9 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Measured: 12 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Measured: 15 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Measured: 3 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Measured: 6 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Measured: 9 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Measured: 12 months after implantation
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Measured: 15 months after implantation
Secondary outcomes (11)
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: before first fitting post-implantation (1 day)
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: 3 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: 6 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: 9 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: 12 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Measured: 15 months after implantation
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Measured: after each fitting (4 weeks after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Measured: after each fitting (3 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Measured: after each fitting (6 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Measured: after each fitting (9 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Measured: after each fitting (12 months after implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startNov 2014
- Primary completion15 Dec 2017
- Study completion15 Dec 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- numerics data GmbH
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, PhD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228148
- Sponsor's protocol ID
- CEL5332
- Status last verified
- Jan 2018
- First submitted
- 27 Aug 2014
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
- ClinicalTrials.gov ID
- NCT02228148
- Acronym / sponsor ID
- CEL5332
- Conditions
- Hearing Loss
- Keywords
- Post linguistically deafness, severe to profound deafness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- numerics data GmbH
- Study start
- Nov 2014
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 28 Aug 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 if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants Recipients with the same hearing outcome as the current and established clinical fitting method with Cochlear Nucleus Custom SoundTM Suite. The Clinical Care Innovation method reduces fitting to simple volume, bass and trebles adjustments, operations which are familiar to anyone who has used an audio player.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFS | Experimental | Device: NFSCochlear Nucleus Fitting Software |
| CSS | Active comparator | Device: CSSCochlear Nucleus Custom SoundTM Suite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly implanted subjects with available Nucleus Cochlear Implants compatible with CP900 series sound processors (excluding Cochlear Nucleus Hybrid)
- Post linguistically deafened adults (≥ 18 years)
- Unilaterally implanted
- ≤ 15 years of severe to profound deafness prior to implantation
- Subjects who are capable and willing to participate in speech perception tests in local language
Key exclusion criteria (8 listed)
- Additional handicaps that would prevent participation in evaluations (e.g. visual impairment, blindness)
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure/fitting method
- Bilateral implantation
- Hybrid-L (not supported by Nucleus Fitting Software)
- Subjects who already have hearing experience with a Cochlear Implant (e.g. reimplantation, contralateral Cochlear Implant)
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 |
|---|---|---|
| NFSCochlear Nucleus Fitting Software | Device | NFS |
| CSSCochlear Nucleus Custom SoundTM Suite | Device | CSS |
Primary outcome
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Time frame: 3 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Time frame: 6 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Time frame: 9 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Time frame: 12 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds
Time frame: 15 months after implantation
Adaptive Oldenburg Sentence Test in noise with speech at 65 dB (if the subject's understanding with Oldenburg Sentence Test in quiet is ≥ 70%).
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Time frame: 3 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Time frame: 6 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Time frame: 9 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Time frame: 12 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via speech performance tests
Time frame: 15 months after implantation
Freiburg Monosyllables and Oldenburg Sentence Test in quiet at 65 dB.
11 secondary outcomes
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: before first fitting post-implantation (1 day)
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: 3 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: 6 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: 9 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: 12 months after implantation
Hearing disability score in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via the Speech Spatial Hearing Qualities questionnaire (without spatial part)
Time frame: 15 months after implantation
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Time frame: after each fitting (4 weeks after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Time frame: after each fitting (3 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Time frame: after each fitting (6 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Time frame: after each fitting (9 months after implantation)
Subject preference for fittings performed with Nucleus Fitting Software and fittings with Nucleus Custom SoundTM Suite assessed via a subject comfort questionnaire
Time frame: after each fitting (12 months after implantation)
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 10 Jan 2018.
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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.
Bart Volckaerts, PhD study director
Cochlear
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NFS and CSS 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 7 inclusion and 8 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 10 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 3 sites in Germany, Switzerland. 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?
Speech perception performance in subjects fitted with Nucleus Fitting Software and subjects fitted with Nucleus Custom SoundTM Suite assessed via aided hearing thresholds (time frame: 3 months after implantation). The study lists 10 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 10 Jan 2018.