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OpenTrials
Active, Not Recruiting

NCT Number: NCT06100393

New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.

The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Melbourne, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • User of an approved Nucleus cochlear implant.
  • User of the ACE (Advanced Combination Encoder) sound processing strategy.
  • Aged 18 years or older (no upper age limit).
  • Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.*
  • Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
  • Willing and able to provide written informed consent.
  • ≥3 months post cochlear implant activation

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 the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  • Cochlear employees or employees of Contract Research Organizations 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 Pre-Processing Algorithm (Sub A)

Device

DNR algorithm

Cochlear Limited standard-of-care pre-processing algorithms

Device

Standard-of-care sound path as implemented in the N8 system

Investigational Pre-Processing Algorithm (Sub B)

Device

Spatial Automation profile

Investigational pre-processing algorithm (Sub D)

Device

Microphone miscalibration profile with applied correction method

Investigational Pre-Processing Algorithm (Sub C)

Device

Spatial Automation profile and DNR algorithm

Investigational Pre-Processing Algorithm (Sub E)

Device

CUSP reference sound path

Primary outcomes

  1. Australian Sentence Test in Noise (AuSTIN)

    Time frame: 1 day - Immediately post-screening

    To determine whether the research algorithm provides non-inferior performance to the standard-of-care algorithm for sentences in noise using an adaptive sentence test in noise scores.

    Scoring: AuSTIN 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 of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients

Acronym: PRESENCE-MU

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2023
Registry last updated
May 28, 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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