NCT06867380

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
47mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
May 2025Apr 2030

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

March 4, 2025

Last Update Submit

March 5, 2026

Conditions

Cochlear Implant RecipientsHearing Loss, Cochlear

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 to 12 weeks

Study Arms (1)

Investigational sound coding strategy/Default sound coding strategy (Sub A)

EXPERIMENTAL

Tested with investigational and default sound coding strategies

Device: Investigational sound coding strategyDevice: Cochlear default sound coding strategy

Interventions

Investigational sound coding strategyDEVICE

SPARC (Stimulation Place and Rate Coding) sound coding strategies

Investigational sound coding strategy/Default sound coding strategy (Sub A)
Cochlear default sound coding strategyDEVICE

ACE (Advanced Combination Encoder) sound coding strategy

Investigational sound coding strategy/Default sound coding strategy (Sub A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HEARnet Clinical studies

Carlton, Victoria, 3053, Australia

Location

Cochlear Melbourne

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigational sound coding strategy and default sound coding comparator is blinded to the participant
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

May 27, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)