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RecruitingNCT07262827STREAMUpdated Aug 26, 2026

Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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+.

02

Conditions studied

  • Cochlear Implant Users
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    All Participants

    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

Interventions

  • DeviceNucleus 8 Sound Processor streaming via MultiMic+

    The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.

  • DeviceNucleus 8 Sound Processor microphones

    Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).

  • DeviceNucleus 8 Sound Processor streaming via Roger 20

    Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.

  • DeviceKanso 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.

  • DeviceKanso 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.

05

What researchers measure

Primary outcomes

  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

    Time frame: At ad-hoc visits between enrolment and 12 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Cochlear Limited
    Sydney, New South Wales 2109, Australia
    Recruiting
07

References and documents

Individual participant data

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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07262827
Lead sponsor
Cochlear
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Mar 12, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Wei Hong
Contact
whong@cochlear.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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