Hearing Loss
Conditions
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
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.
Interventions
DEVICEU8
The U8 Research System
DEVICEN8 sound processor
Nucleus 8 sound processor
Sponsors
Avania
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Outcome results
None listed