Hearing Loss
Conditions
Brief summary
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation. Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation. A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks. The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.
Interventions
DEVICESPACE
SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants.
DEVICEOPAL-SPACE
OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively.
DEVICEACE
Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.
DEVICECochlear Device Interface (CDI) Tool
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
Sponsors
Trium Clinical Consulting
Avania
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding. * Paediatrics: Older than 5 years and \<18 years when entering the study. (Belgium only) or * Adults: ≥18 years when entering the study (Belgium and Australia). * Subject/legally designated representative is fluent speaker in the language used for assessments. * Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).
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. * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monosyllabic Word in Quiet Scores. | One Day | Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome |
Countries
Australia, Belgium
Participant flow
Pre-assignment details
The participant flow includes only one group as this was a repeated measures, single-arm study where all participants were exposed to all sound processing strategies. Data from the same participants was collected multiple times across different conditions. The focus was on assessing effects within the same group under varying conditions, making it a single-arm design with repeated measurements on each participant.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).
SPACE: SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants.
OPAL-SPACE: OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively.
ACE: Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.
Cochlear Device Interface (CDI) Tool: For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: CDI Tool. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 69 years | — |
| Clinical Device in Test Ear N7 CI24RE | 3 Participants | — |
| Clinical Device in Test Ear N7 CI512 | 5 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Monosyllabic Word in Quiet Scores.
Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome
Time frame: One Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Monosyllabic Word in Quiet Scores. | ACE Strategy | 51 Percentage of words repeated correctly | Standard Deviation 14.97 |
| All Participants | Monosyllabic Word in Quiet Scores. | SPACE Strategy | 51.25 Percentage of words repeated correctly | Standard Deviation 10.95 |
| All Participants | Monosyllabic Word in Quiet Scores. | OPAL-SPACE Strategy | 48.50 Percentage of words repeated correctly | Standard Deviation 14.45 |