Cochlear Implant Recipients, Hearing Loss, Cochlear
Conditions
Brief summary
This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.
Interventions
DEVICEInvestigational sound coding strategy
SPARC (Stimulation Place and Rate Coding) sound coding strategies
DEVICECochlear default sound coding strategy
ACE (Advanced Combination Encoder) sound coding strategy
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Investigational sound coding strategy and default sound coding comparator is blinded to the participant
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Users of an approved Nucleus cochlear implant. * Aged 18 years or older (no upper age limit). * Open set speech understanding sufficient to complete the study protocol as judged by the investigator. * Fluent speaker in the language used to assess speech perception performance, as determined by the investigator. * Willing and able to provide written informed consent.
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 their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees or employees of Contract Research Organisations 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 |
|---|---|---|
| Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy | 0 to 12 weeks | Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It 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
Outcome results
None listed