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

NCT ID: NCT06100393

Last Updated: 2025-12-05

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-22

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execution of a series of sub-investigations in the same user population, with the goal to evaluate a range of speech enhancement pre-processing algorithms in separate sub-investigations. The primary objectives for each sub-investigation will be consistent with the master umbrella investigation, with secondary and exploratory objectives selected based on the algorithm to be investigated. Secondary and exploratory objectives will be described in the sub-investigation documentation.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Order of IMD and comparator is blinded.

Study Groups

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Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)

Group Type OTHER

Investigational Pre-Processing Algorithm (Sub A)

Intervention Type DEVICE

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

Intervention Type DEVICE

Automatic Gain Control, SNR-NR, Forward Focus

Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)

Using Spatial Automation Profile

Group Type OTHER

Cochlear Limited standard-of-care pre-processing algorithms

Intervention Type DEVICE

Automatic Gain Control, SNR-NR, Forward Focus

Investigational Pre-Processing Algorithm (Sub B)

Intervention Type DEVICE

Spatial Automation profile

Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)

Group Type OTHER

Investigational pre-processing algorithm (Sub D)

Intervention Type DEVICE

Microphone miscalibration profile with applied correction method

Cochlear Limited standard-of-care pre-processing algorithms

Intervention Type DEVICE

Standard microphone calibration profile

Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)

Using Spatial Automation Profile and DNR technology

Group Type OTHER

Cochlear Limited standard-of-care pre-processing algorithms

Intervention Type DEVICE

Automatic Gain Control, SNR-NR, Forward Focus

Investigational Pre-Processing Algorithm (Sub C)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Cochlear Limited standard-of-care pre-processing algorithms

Automatic Gain Control, SNR-NR, Forward Focus

Intervention Type DEVICE

Investigational Pre-Processing Algorithm (Sub B)

Spatial Automation profile

Intervention Type DEVICE

Investigational pre-processing algorithm (Sub D)

Microphone miscalibration profile with applied correction method

Intervention Type DEVICE

Cochlear Limited standard-of-care pre-processing algorithms

Standard microphone calibration profile

Intervention Type DEVICE

Investigational Pre-Processing Algorithm (Sub C)

Spatial Automation profile and DNR algorithm

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cochlear Melbourne

Melbourne, Victoria, Australia

Site Status RECRUITING

HEARnet Clinical Studies

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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PRS Specialist

Role: CONTACT

+61294286555

PRS Specialist

Role: CONTACT

+612294286555

Facility Contacts

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Linty McDonald

Role: primary

+61 391236633

Karyn Galvin, PhD

Role: primary

+61 407052505

Other Identifiers

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AI5842

Identifier Type: -

Identifier Source: org_study_id

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