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NCT05866770 | Recruiting | Hearing Loss

A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
Sponsor:

Cochlear

Brief Summary:

A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

Condition or disease

Hearing Loss

Intervention/treatment

U8

N8 sound processor

Phase

Not Applicable

Detailed Description:

The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.}}

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
Actual Study Start Date : September 11, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026
Arm Intervention/treatment

Other: U8 then N8

Participants in this arm receive U8 followed by N8

Device: U8

Device: N8 sound processor

Other: N8 then U8

Participants in this arm receive N8 followed by U8

Device: U8

Device: N8 sound processor
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Eighteen years of age or older
  • User of CI600, CI500 or CI24RE implant
  • At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
  • Fluent speaker of English
  • A word speech recognition score of 20% or more when using the cochlear implant alone*
  • Willing and able to provide written informed consent *This can be based on clinical data if collected within the last 12 months
  • Exclusion criteria
    • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
    • Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling
    • Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
    • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. (Unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.
A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

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A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Australia, Melbourne

Cochlear Melbourne

Melbourne E., Melbourne, Australia, 3002

Recruiting

Australia, New South Wales

Cochlear Macquarie

Sydney, New South Wales, Australia, 2113

Recruiting

Australia, Victoria

HEARnet Clinical Studies

Carlton, Victoria, Australia, 3053