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

Cochlear

Status: Not yet enrolling

Conditions: Cochlear Implant Users

Treatments: Device: Nucleus 8 Sound Processor streaming via Roger 20; Device: Kanso 3 Sound Processor streaming via Multi-Mic+; Device: Nucleus 8 Sound Processor streaming via MultiMic+; Device: Kanso 3 Sound Processor microphone; Device: Nucleus 8 Sound Processor microphones

Study type: Interventional

Funder types: Industry

Identifiers

NCT07262827

CLTD5844

Details and patient eligibility

About

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+.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

All Participants

Experimental group

Description:

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.

Treatment:

Device: Kanso 3 Sound Processor microphone

Device: Nucleus 8 Sound Processor microphones

Device: Nucleus 8 Sound Processor streaming via MultiMic+

Device: Kanso 3 Sound Processor streaming via Multi-Mic+

Device: Nucleus 8 Sound Processor streaming via Roger 20