Cochlear Implant Users
Conditions
Brief summary
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+.
Interventions
DEVICENucleus 8 Sound Processor streaming via MultiMic+
The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory.
DEVICENucleus 8 Sound Processor microphones
Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2).
DEVICENucleus 8 Sound Processor streaming via Roger 20
Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory.
DEVICEKanso 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.
DEVICEKanso 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.
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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) |
Countries
Australia
Contacts
CONTACTWei Hong
Outcome results
None listed