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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-02-22

Primary completion: 2026-10-31

Study completion finish: 2026-10-31

Study type

BASIC_SCIENCE

Phase

Trial ID

NCT06100393

Intervention or treatment

DEVICE: Investigational Pre-Processing Algorithm (Sub A)

DEVICE: Cochlear Limited standard-of-care pre-processing algorithms

DEVICE: Investigational Pre-Processing Algorithm (Sub B)

Conditions

• Hearing Loss

Condition: Hearing Loss
DEVICE: Investigational Pre-Processing Algorithm (Sub A) and other drugs
Melbourne, Victoria, Australia and more
Sponsor: Cochlear

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Find a site

Closest Location:

Cochlear Melbourne

Research sites nearby

Select from list below to view details:

Cochlear Melbourne
Melbourne, Victoria, Australia
HEARnet Clinical Studies
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
OTHER: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A) Not Specified	DEVICE: 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.
OTHER: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B) Using Spatial Automation Profile	DEVICE: Cochlear Limited standard-of-care pre-processing algorithms Automatic Gain Control, SNR-NR, Forward Focus

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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

Secondary outcome

Frequently Asked Questions

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References

Clinical Trials Gov: New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.