Clinical trial NCT05866770: A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2023-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Percent correct monosyllabic word scores.
timeFrame: 3 months
measure: Adaptive sentence in noise scores (AuSTIN)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne E.
country: Australia
facility: Cochlear Melbourne
state: melbourne
city: Sydney
country: Australia
facility: Cochlear Macquarie
state: New South Wales
city: Carlton
country: Australia
facility: HEARnet Clinical Studies
state: Victoria
Study officials:
References: