An interventional study of Nucleus 8 Sound Processor streaming via MultiMic+ and Nucleus 8 Sound Processor microphones in Cochlear Implant Users, sponsored by Cochlear. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Cochlear · Not applicable, Interventional, and Other
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+.
Exclusion Criteria:
Participants will be fit with either Nucleus 8 or Kanso 3 Sound Processors with LE Audio investigational firmware. Comparisons will be made within-participant with repeated measures for each of the speech perception scores in noise conditions.
Device: Nucleus 8 Sound Processor streaming via MultiMic+ · Device: Nucleus 8 Sound Processor microphones · Device: Nucleus 8 Sound Processor streaming via Roger 20 · Device: Kanso 3 Sound Processor streaming via Multi-Mic+ · Device: Kanso 3 Sound Processor microphone
The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.
Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).
Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.
Kanso 3 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. This includes the Kanso 3 Nexa Sound Processor.
Kanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor.
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
Time frame: At ad-hoc visits between enrolment and 12 months
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Nucleus 8 streaming via the Multi-Mic+ and Nucleus 8 streaming via the Roger 20 system at -15 dB SNR in 65 dB SPL
Time frame: At ad-hoc visits between enrolment and 12 months
Paired difference in CUNY Sentences scores (% words correct) in classroom-like noise between Kanso 3 streaming via Multi-Mic+ and Kanso 3 processor microphones (SCAN 2) at 0 dB SNR in 65 dB SPL
Time frame: At ad-hoc visits between enrolment and 12 months
Ratings based on the Device Use Questionnaire after a minimum of two weeks actual-use of the new GN ReSound accessories in the real-world environment
The custom device use questionnaire is designed to collect information regarding the participants' experience using the research sound processors with the interventional accessories using a 5-point Likert scale (very satisfied, satisfied, neither dissatisfied nor satisfied, dissatisfied, very dissatisfied)
Time frame: At ad-hoc visits between enrolment and 12 months
Plan to share: No — Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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