Low-energy (LE) Bluetooth audio streaming with Nucleus 8 and Kanso 3 sound processors

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cochlear (Industry-sponsored)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT07262827 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Sydney, New South Wales

• Cochlear Limited — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: PRS Specialist

Conditions Cochlear Implant Users