New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
PRESENCE-MU
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: a Master Umbrella Investigation
1 other identifier
interventional
150
1 country
2
Brief Summary
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of several sub-investigations, which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
February 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
December 5, 2025
September 1, 2025
2.7 years
October 2, 2023
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Australian Sentence Test in Noise (AuSTIN)
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.
1 day - Immediately post-screening
Study Arms (4)
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
OTHERInvestigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
OTHERUsing Spatial Automation Profile
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
OTHEROther: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
OTHERUsing Spatial Automation Profile and DNR technology
Interventions
The algorithms act upon the digital audio signal received by the microphones and other sensors to enhance speech and attenuate noise prior to encoding the signal for delivery to a cochlear implant via the specified system.
Spatial Automation profile
Microphone miscalibration profile with applied correction method
Spatial Automation profile and DNR algorithm
Automatic Gain Control, SNR-NR, Forward Focus
Eligibility Criteria
You may qualify if:
- 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
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 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (2)
Cochlear Melbourne
Melbourne, Victoria, 3002, Australia
HEARnet Clinical Studies
Melbourne, Victoria, 3053, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Order of IMD and comparator is blinded.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 25, 2023
Study Start
February 22, 2024
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share