Low-energy (LE) Bluetooth audio streaming with Nucleus 8 and Kanso 3 sound processors
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
Run by Cochlear · NCT07262827 · Data updated 2026-11-12
This project will test whether low-energy (LE) Bluetooth audio streaming is accepted and works well for experienced adult cochlear implant users who use Nucleus 8 or Kanso 3 processors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Cochlear Industry-sponsored |
| Locations | 1 site (Sydney, New South Wales) |
| Status | Recruiting |
| Started | March 12, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07262827 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with at least three months' experience using an eligible Cochlear implant (CI1000, CI600, CI500, Freedom, or N24 series) who can score ≥30% at +15 dB SNR on a sentence‑in‑noise test and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients who are not implanted with eligible device models, who have additional disabilities preventing participation, who cannot comply with protocol requirements, or who have unrealistic expectations about benefits may not receive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Experienced adult cochlear implant users will take home and use final-release LE Audio firmware on Nucleus 8 and Kanso 3 processors along with GN ReSound LE Audio accessories such as the Multi‑Mic+. Participants will use the devices in real-world settings and complete lab speech‑in‑noise testing with streaming via the Multi‑Mic+. The study compares streaming performance and user acceptance of LE Audio versus standard microphone input and other streaming accessories. Data collected include speech perception in noise scores and user feedback on acceptability and everyday performance.
Why it matters
Potential benefit: If successful, LE Audio streaming could improve wireless audio quality, hands‑free connectivity, and the listening experience for cochlear implant users in noisy environments.
How similar studies have gone: LE Audio is a relatively new wireless standard with limited published clinical data in cochlear implant users, although prior studies of conventional wireless streaming and remote microphones have shown improved speech‑in‑noise performance.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Cochlear Limited
Sydney, New South Wales, Australia Recruiting
Study contacts
- Study coordinator: Wei Hong
- Email: whong@cochlear.com
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Binaural listening and its effects on listening effort and development in Mandarin-speaking children with cochlear implants
This study will test whether listening with two ears (two cochlear implants or a cochlear implant plus a hearing aid) reduces mental effort and helps brain, social, and daily-life development in Mandarin-speaking children aged 6–18 who use cochlear implants compared with children with normal hearing.
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The researchers will test whether measuring listening effort with pupil tracking and using realistic speech tasks can explain and improve how adults with cochlear implants understand everyday conversations.
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Early use of a cochlear implant in the first year
This project will test whether adults newly fitted with a cochlear implant notice changes in simple sound perception and improved speech understanding during their first year of device use using take-home and lab listening tests.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.