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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+.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleus 8 Sound Processor streaming via MultiMic+ | Device | The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Contact | +61294286555 | cltd-prs-admin@cochlear.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Limited | Recruiting | Sydney | New South Wales | 2109 | Australia |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| 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. |
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| 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. |
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| 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. |
|
| 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 | 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) | At ad-hoc visits between enrolment and 12 months |