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

NCT ID: NCT07262827

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-10-31

Brief Summary

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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+.

Detailed Description

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Conditions

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Cochlear Implant Users

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nucleus 8 Sound Processor streaming via MultiMic+

Intervention Type DEVICE

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

Nucleus 8 Sound Processor microphones

Intervention Type DEVICE

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

Nucleus 8 Sound Processor streaming via Roger 20

Intervention Type DEVICE

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

Kanso 3 Sound Processor streaming via Multi-Mic+

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Nucleus 8 Sound Processor streaming via MultiMic+

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

Intervention Type DEVICE

Nucleus 8 Sound Processor microphones

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

Intervention Type DEVICE

Nucleus 8 Sound Processor streaming via Roger 20

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cochlear Limited

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Central Contacts

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PRS Specialist

Role: CONTACT

+61294286555

Facility Contacts

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PRS Specialist

Role: primary

+61294286555

Other Identifiers

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CLTD5844

Identifier Type: -

Identifier Source: org_study_id

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