Cochlear Implant RecipientsSONORA-MUNCT06867380

An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients

A study testing Investigational sound coding strategy A, Cochlear default sound coding strategy A and Investigational sound coding strategy B in people with Cochlear Implant Recipients and Hearing Loss, Cochlear, run by Cochlear at 2 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cochlear Implant Recipients, Hearing Loss, Cochlear
What is being tested?: Investigational sound coding strategy A, Cochlear default sound coding strategy A and Investigational sound coding strategy B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesAustralia
Study dates: 27 May 2025to Apr 2030
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Users of an approved Nucleus cochlear implant.
Aged 18 years or older (no upper age limit).
Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
Willing and able to provide written informed consent.

Who cannot join

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

HEARnet Clinical studies
Carlton, Victoria, 3053
Cochlear Melbourne
East Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official title: A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: A Master Umbrella Investigation

This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.

Conditions: Cochlear Implant Recipients, Hearing Loss, Cochlear
Being tested: Investigational sound coding strategy A, Cochlear default sound coding strategy A, Investigational sound coding strategy B, Cochlear default sound coding strategy B
Medical subject headings: Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational sound coding strategy ADevice
SPARC (Stimulation Place and Rate Coding) sound coding strategies
Cochlear default sound coding strategy ADevice
ACE (Advanced Combination Encoder) sound coding strategy
Investigational sound coding strategy BDevice
SPARC (Stimulation Place and Rate Coding) sound coding strategies with focused stimulation.
Cochlear default sound coding strategy BDevice
Cochlear default sound coding strategy ACE (Advanced Combination Encoder) sound coding strategy with focused stimulation.

Study groups in NCT06867380
Study group	Role	What they receive
Investigational sound coding strategy/Default sound coding strategy (Sub A)	Experimental	Tested with investigational and default sound coding strategies Receives: Device: Investigational sound coding strategy A; Device: Cochlear default sound coding strategy A
Investigational sound coding strategy/Default sound coding strategy (Sub B)	Experimental	Tested with investigational and default sound coding strategies Receives: Device: Investigational sound coding strategy B; Device: Cochlear default sound coding strategy B

What is being measured

The primary outcome is the main question the study is designed to answer.

Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.
Measured: 0 to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 2025Apr 2030

First posted10 Mar 2025
Study start27 May 2025
Primary completionApr 2030 (estimated)
Study completionApr 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cochlear Implant RecipientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06867380
Sponsor's protocol ID: AI5838
Acronym: SONORA-MU
Status last verified: Oct 2026
First submitted: 4 Mar 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No