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"Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus (NCT03026829)

The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.
  • Device: CART sound therapy
    The study consists of two parts: Phase 1: laboratory evaluation of CART sound acceptability Phase 2: take home evaluation of CART sound therapy including baseline without CART
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • 18 years of age or older
    • Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
    • At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
    • Native speaker and fluency in the language used in the assessments (i.e. Dutch)
    Exclusion Criteria:
    • Additional handicaps that would prevent participation in evaluations
    • History of psychiatric disorders or depression (on investigator's opinion)
    • Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
    • Pulsatile or diagnosed objective / middle ear tinnitus

    1 locations

    Netherlands (1)
    • Department of Otorhinolaryngology, Maastricht University Medical Centre
      not yet recruiting
      Maastricht, Limburg, Netherlands
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    14 September, 2017
    Updated:
    27 June, 2017
    Participants:
    50
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