Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
Nucleus 8 Sound Processor streaming via MultiMic+Nucleus 8 Sound Processor microphonesNucleus 8 Sound Processor streaming via Roger 20Kanso 3 Sound Processor streaming via Multi-Mic+Kanso 3 Sound Processor microphone
Nucleus 8 Sound Processor streaming via MultiMic+: The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.
Nucleus 8 Sound Processor microphones: Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).
Nucleus 8 Sound Processor streaming via Roger 20: Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.
Kanso 3 Sound Processor streaming via Multi-Mic+: 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 microphone: Kanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor.
Study 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+.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18 years or older
2. Implanted with at least one of the CI1000 Series, CI600 Series, CI500 Series, Freedom Series or N24 Series cochlear hearing implants.
3. At least 3 months experience with a cochlear hearing implant
4. Demonstrated ability to score 30% or more at +15 SNR with Cochlear implant alone on a sentence in noise test.
5. Willingness to participate in and to comply with all requirements of the protocol
6. Fluent speaker in English as determined by the investigator
7. Willing and able to provide written informed consent.
Exclusion Criteria:
1. Additional disabilities that would prevent participation in evaluations
2. Unrealistic expectations on the part of the participant, regarding the possible benefits, risks and limitations that are inherent to the procedures
3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. 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).
Primary outcome measure(s)
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 — At ad-hoc visits between enrolment and 12 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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