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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCochlear

About this trial

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+.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: All ParticipantsExperimental treatment 5 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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