New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCochlear
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.*
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Investigational Pre-Processing Algorithm (Sub A)
DeviceDNR algorithm
Cochlear Limited standard-of-care pre-processing algorithms
DeviceStandard-of-care sound path as implemented in the N8 system
Investigational Pre-Processing Algorithm (Sub B)
DeviceSpatial Automation profile
Investigational pre-processing algorithm (Sub D)
DeviceMicrophone miscalibration profile with applied correction method
Investigational Pre-Processing Algorithm (Sub C)
DeviceSpatial Automation profile and DNR algorithm
Investigational Pre-Processing Algorithm (Sub E)
DeviceCUSP reference sound path
Treatment groups
150 Participants
are divided into 5 treatment groupsGroup A: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub A)Experimental treatment 2 interventions
Group B: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub B)Experimental treatment 2 interventions
Group C: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub D)Experimental treatment 2 interventions
Group D: Other: Investigational pre-processing algorithm/Standard of Care pre-processing algorithm (Sub C)Experimental treatment 2 interventions
Group E: Investigational Pre-Processing Algorithm/Standard of Care pre-processing algorithm (Sub E)Experimental treatment 2 interventions
Trial outcomes
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.
Time frame
1 day - Immediately post-screening Source ClinicalTrials.gov