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Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)

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ClinicalTrials.gov Identifier: NCT02228148
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
numerics data GmbH
Information provided by (Responsible Party):
Cochlear

Brief 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 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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: NFS Device: CSS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Fitting Methods Using Cochlear Clinical Care Innovation
Study Start Date : November 2014
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NFS
Cochlear Nucleus Fitting Software
Device: NFS
Cochlear Nucleus Fitting Software

Active Comparator: CSS
Cochlear Nucleus Custom SoundTM Suite
Device: CSS
Cochlear Nucleus Custom SoundTM Suite




Primary Outcome Measures :
  1. 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%).

  2. 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%).

  3. 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%).

  4. 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%).

  5. 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%).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228148


Locations
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Germany
Deutsches HörZentrum Hannover der HNO-Klinik der MHH
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Hals, Nasen-, Ohrenheilkunde, Kopf und Halschirurgie
Kiel, Schleswig-Holstein, Germany, 24105
Switzerland
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital
Zurich, Kanton Zurich, Switzerland, 8091
Sponsors and Collaborators
Cochlear
numerics data GmbH
Investigators
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Study Director: Bart Volckaerts, PhD Cochlear

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02228148    
Other Study ID Numbers: CEL5332
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Keywords provided by Cochlear:
Post linguistically deafness, severe to profound deafness
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms