New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
NCT ID: NCT06100393
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-02-22
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)
Investigational Pre-Processing Algorithm (Sub A)
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.
Cochlear Limited standard-of-care pre-processing algorithms
Automatic Gain Control, SNR-NR, Forward Focus
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)
Using Spatial Automation Profile
Cochlear Limited standard-of-care pre-processing algorithms
Automatic Gain Control, SNR-NR, Forward Focus
Investigational Pre-Processing Algorithm (Sub B)
Spatial Automation profile
Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)
Investigational pre-processing algorithm (Sub D)
Microphone miscalibration profile with applied correction method
Cochlear Limited standard-of-care pre-processing algorithms
Standard microphone calibration profile
Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)
Using Spatial Automation Profile and DNR technology
Cochlear Limited standard-of-care pre-processing algorithms
Automatic Gain Control, SNR-NR, Forward Focus
Investigational Pre-Processing Algorithm (Sub C)
Spatial Automation profile and DNR algorithm
Interventions
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Investigational Pre-Processing Algorithm (Sub A)
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.
Cochlear Limited standard-of-care pre-processing algorithms
Automatic Gain Control, SNR-NR, Forward Focus
Investigational Pre-Processing Algorithm (Sub B)
Spatial Automation profile
Investigational pre-processing algorithm (Sub D)
Microphone miscalibration profile with applied correction method
Cochlear Limited standard-of-care pre-processing algorithms
Standard microphone calibration profile
Investigational Pre-Processing Algorithm (Sub C)
Spatial Automation profile and DNR algorithm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Locations
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Cochlear Melbourne
Melbourne, Victoria, Australia
HEARnet Clinical Studies
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AI5842
Identifier Type: -
Identifier Source: org_study_id
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