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NCT Number: NCT06867380

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HEARnet Clinical studies, Carlton, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Investigational sound coding strategy

Device

SPARC (Stimulation Place and Rate Coding) sound coding strategies

Cochlear default sound coding strategy

Device

ACE (Advanced Combination Encoder) sound coding strategy

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

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

Acronym: SONORA-MU

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 10, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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