Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nucleus 8 Sound Processor streaming via MultiMic+, Nucleus 8 Sound Processor microphones, Nucleus 8 Sound Processor streaming via Roger 20, Kanso 3 Sound Processor streaming via Multi-Mic+.
- Who it may be relevant to
- Registry conditions: Cochlear Implant Users. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pre-market, Prospective, Within-subject, Open-label, Interventional Investigation of Acceptance and Performance of Wireless Streaming Via Low Energy Audio Introduced Into the Firmware of the Nucleus 8 and Kanso 3 Sound Processors Worn by Experienced Adult Cochlear Implant Recipients
Overview
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
- Device Nucleus 8 Sound Processor streaming via MultiMic+
The Nucleus 8 Sound Processor streaming audio via the Multi-Mic+ wireless microphone accessory. - Device Nucleus 8 Sound Processor microphones
Nucleus 8 Sound Processor streaming via the Nucleus 8 Sound Processor microphones (SCAN 2). - Device Nucleus 8 Sound Processor streaming via Roger 20
Nucleus 8 Sound Processor streaming audio via the Roger 20 wireless microphone accessory. - 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. - 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.
Primary outcome measures
- 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 outcome measures (3)
- 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]
- 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]
- 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 [Time frame: At ad-hoc visits between enrolment and 12 months]
Eligibility criteria
Inclusion criteria
- 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.
- Willingness to participate in and to comply with all requirements of the protocol
- Fluent speaker in English as determined by the investigator
- Willing and able to provide written informed consent.
Exclusion criteria
- 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.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Australia · 1 center
- Cochlear Limited — Sydney
Identifiers
NCT: NCT07262827 · CLTD5844