Phase
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
Ages > 18 All Genders
Study Summary
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
Connect with a study center
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
University of Bari "A. Moro" UOC Otorinolaringoiatria Universitaria
Bari, 70120
ItalySite Not Available
Azienda Ospedale Università di Padova
Padova, 35128
ItalySite Not Available
Academisch Ziekenhuis Maastricht
Maastricht, 6229 EV
NetherlandsSite Not Available
Radboud University Medical Centre Nijmegen
Nijmegen, 6500 HB
NetherlandsSite Not Available
Queen Elizabeth Hospital Audiology Centre - University Hospital Birmingham
Birmingham, B15 2TH
United KingdomSite Not Available
Auditory Implant Centre, Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ
United KingdomActive - Recruiting
St George's Hospital
London, SW17 0QT
United KingdomSite Not Available
St Thomas' Hospital
London, SE1 7EH
United KingdomActive - 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.