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NCT Number: NCT07262827

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

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+.

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Key information

Conditions

Cochlear Implant Users

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Limited

Sydney, New South Wales, 2109, Australia

Location status: Recruiting

Location contact

PRS Specialist

CONTACT

[email protected]

+61294286555

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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).

Treatment and study plan

Nucleus 8 Sound Processor streaming via MultiMic+

Device

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

Nucleus 8 Sound Processor microphones

Device

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

Nucleus 8 Sound Processor streaming via Roger 20

Device

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

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.

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.

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

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

PRS Specialist

CONTACT

[email protected]

+61294286555

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients

Acronym: STREAM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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