Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEInvestigational Pre-Processing Algorithm (Sub A)
DNR algorithm
DEVICECochlear Limited standard-of-care pre-processing algorithms
Standard-of-care sound path as implemented in the N8 system
DEVICEInvestigational Pre-Processing Algorithm (Sub B)
Spatial Automation profile
DEVICEInvestigational pre-processing algorithm (Sub D)
Microphone miscalibration profile with applied correction method
DEVICEInvestigational Pre-Processing Algorithm (Sub C)
Spatial Automation profile and DNR algorithm
DEVICEInvestigational Pre-Processing Algorithm (Sub E)
CUSP reference sound path
Sponsors
Cochlear
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Order of IMD and comparator is blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Australian Sentence Test in Noise (AuSTIN) | 1 day - Immediately post-screening | 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. |
Countries
Australia
Contacts
CONTACTLinty McDonald
Outcome results
None listed