An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients (SONORA-MU)

March 5, 2026 updated by: Cochlear

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • HEARnet Clinical Studies
      • East Melbourne, Victoria, Australia, 3002
        • Cochlear Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational sound coding strategy/Default sound coding strategy (Sub A)
Tested with investigational and default sound coding strategies
Device: Investigational sound coding strategy
SPARC (Stimulation Place and Rate Coding) sound coding strategies
Device: Cochlear default sound coding strategy
ACE (Advanced Combination Encoder) sound coding strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
Time Frame: 0 to 12 weeks
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.
0 to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI5838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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