Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso… (NCT07262827) | Clinical Trial Compass
RecruitingNot Applicable
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
Australia20 participantsStarted 2026-03
Plain-language summary
This study aims to investigate acceptance and performance of the Bluetooth Low Energy Audio-enabled (LE Audio) firmware in the Nucleus 8 Processing Unit, Kanso 3 Nexa Sound Processor, and the Kanso 3 Sound Processor. The investigation includes actual use (take home) of LE Audio firmware releases and the new GN ReSound LE Audio wireless accessories, including the Multi-Mic+, for use in the real-world. Using the final versions of firmware, speech perception performance in noise will be investigated using the Nucleus 8 and Kanso 3 Sound Processors streaming via a Multi-Mic+.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 18 years or older
✓. Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
✓. At least 3 months experience with a cochlear hearing implant
✓. Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
✓. Willingness to participate in and to comply with all requirements of the protocol
✓. Fluent speaker in English as determined by the investigator
✓. Willing and able to provide written informed consent.
Exclusion criteria
✕. Additional disabilities that would prevent participation in evaluations
✕. Unrealistic expectations on the part of the participant, regarding the possible benefits, risks and limitations that are inherent to the procedures
What they're measuring
1
Paired difference in City University of New York (CUNY) Sentences scores (% words correct) in classroom-like noise between the Nucleus 8 streaming via Multi-Mic+ and Nucleus 8 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Timeframe: At ad-hoc visits between enrolment and 12 months
. 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.
✕. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).