A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Percent correct monosyllabic word scores. — 3 months To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level)
Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.
Adaptive sentence in noise scores (AuSTIN) — 3 months To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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