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

NCT07262827 | Recruiting

• 1 other identifier: CLTD5844
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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+.

Conditions

Cochlear Implant Users

Outcome Measures

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

  At ad-hoc visits between enrolment and 12 months

Secondary Outcomes (3)

• 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

  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

  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

  At ad-hoc visits between enrolment and 12 months

Study Arms (1)

All Participants

EXPERIMENTAL

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

Nucleus 8 Sound Processor streaming via MultiMic+ DEVICE

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

All Participants

Nucleus 8 Sound Processor microphones DEVICE

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

All Participants

Nucleus 8 Sound Processor streaming via Roger 20 DEVICE

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

All Participants

Kanso 3 Sound Processor streaming via Multi-Mic+ DEVICE

Kanso 3 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. This includes the Kanso 3 Nexa Sound Processor.

All Participants

Kanso 3 Sound Processor microphone DEVICE

Kanso 3 Sound Processor streaming audio via the Kanso 3 Sound Processor microphones (SCAN 2). This includes the Kanso 3 Nexa Sound Processor.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Cochlear Limited

Sydney, New South Wales, 2109, Australia

RECRUITING

Central Study Contacts

PRS Specialist

CONTACT

+61294286555; cltd-prs-admin@cochlear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 4, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)