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Completed

NCT Number: NCT02228148

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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches HörZentrum Hannover der HNO-Klinik der MHH, Hanover, Lower Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NFS

Device

Cochlear Nucleus Fitting Software

CSS

Device

Cochlear Nucleus Custom SoundTM Suite

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • numerics data GmbH

Registry information

Official study title

Comparison of Fitting Methods Using Cochlear Clinical Care Innovation

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2014
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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