Actively Recruiting
Investigation of Acceptance and Performance of Wireless Streaming Using Low Energy Audio in Nucleus 8 and Kanso 3 Sound Processors by Experienced Adult Cochlear Implant Users
Led by Cochlear · Updated on 2026-05-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the acceptance and performance of Bluetooth Low Energy (LE) Audio firmware added to the Nucleus 8 and Kanso 3 Sound Processors worn by experienced adult cochlear implant users. This study aims to understand how well the LE Audio streaming and new GN ReSound wireless accessories, including the Multi-Mic+, work in real-world settings and improve speech perception in noisy environments. Participants will use either the Nucleus 8 or Kanso 3 Sound Processors equipped with investigational LE Audio firmware. The study compares speech perception scores in noise within the same participants using different setups: streaming via the Multi-Mic+, processor microphones (SCAN 2), and the Roger 20 system. The use of these devices and firmware updates will be assessed over time with repeated measures. During the study, participants will be monitored through ad-hoc visits up to 12 months after enrollment. Speech perception will be tested using City University of New York (CUNY) Sentences in simulated noisy settings. Device usage and acceptance in everyday environments will be evaluated using questionnaires. The study will collect data on word recognition performance and user feedback to assess the new wireless streaming technology with cochlear implants.
CONDITIONS
Brief Title
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Implanted with at least one of the following cochlear implants: CI1000 Series, CI600 Series, CI500 Series, Freedom Series, or N24 Series
- At least 3 months experience using a cochlear implant
- Ability to score 30% or more on a sentence-in-noise test at +15 SNR using the cochlear implant alone
- Willingness to participate and comply with all study requirements
- Fluent in English as determined by the investigator
- Willing and able to provide written informed consent
You will not qualify if you...
- Additional disabilities preventing participation in evaluations
- Unrealistic expectations about the benefits, risks, or limitations of the study
- Inability or unwillingness to comply with the study requirements
- Investigator site personnel or immediate family members involved in the study
- Current participation or recent participation (within 30 days) in another interventional clinical study involving an investigational drug or device, unless Cochlear sponsored and approved by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with investigational firmware and use various streaming methods for assessment.
Ad-hoc visits between enrollment and 12 months
Trial Site Locations
Total: 1 location
1
Cochlear Limited
Sydney, New South Wales, Australia, 2109
Actively Recruiting
Research Team
P
PRS Specialist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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