Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

Last updated: May 15, 2024
Sponsor: Cochlear
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)

Cochlear™ Remote care

Standard of care

Clinical Study ID

NCT05552118
CLTD5764
  • Ages > 18
  • All Genders

Study Summary

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older (no upper age limit)

  • Post-lingually deafened

  • Unilaterally implanted with the CI600 Series (CI612, CI622, CI632),CI500 Series (CI512, CI522, CI532) or Freedom Series (CI24RE(CA),CI24RE(ST), CI422)

  • Currently using a Nucleus 7 (CP1000) or Kanso 2 (CP1050) Sound Processor (or latestcompatible Sound Processor)

  • 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at thetime of baseline measurements

  • Owner of a compatible Smart Phone

  • Fluent in the languages used for the study, as determined by the investigator

  • Willing to participate in and comply with all requirements of the protocol,including willingness to be randomised to either arm

  • Willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  • Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT)programming:

  • Non-monopolar MAPs (bipolar, common ground, variable mode)

  • Dynamic range of <10 Comfortable Level (CL)

  • Hybrid mode enabled

  • Pulse widths >100 µs

  • 10 or more electrodes turned off

  • Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances

  • Patient requires frequent individual channel measurements and/or measurementswithout the use of live-stimulation

  • Score below 3 on the screening subset of questions from the Mobile DeviceProficiency Questionnaire (MDPQ)

  • Abnormal cochlea anatomy and/or facial nerve stimulation

  • Additional disabilities that would prevent participation in evaluations, includingsignificant visual impairment and/or dexterity issues

  • Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator

  • Investigator site personnel directly affiliated with this study and/or theirimmediate families; immediate family is defined as a spouse, parent, child, orsibling

  • Cochlear employees or employees of Contract Research Organisations or contractorsengaged by Cochlear for the purposes of this investigation

  • Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation).

Study Design

Total Participants: 148
Treatment Group(s): 3
Primary Treatment: Cochlear Implant CI600 Series, CI500 Series or Freedom Series and Sound processor Nucleus 7 or Kanso 2 (or latest compatible Sound Processor)
Phase:
Study Start date:
March 18, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria

    Bari, 70120
    Italy

    Site Not Available

  • Azienda Ospedale Università di Padova

    Padova, 35128
    Italy

    Site Not Available

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 EV
    Netherlands

    Site Not Available

  • Radboud University Medical Centre Nijmegen

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Auditory Implant Centre, Glan Clwyd Hospital

    Bodelwyddan, LL18 5UJ
    United Kingdom

    Active - Recruiting

  • St George's Hospital

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.