Sound Processing. ( A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation)

Study Overview
=================
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.

Official Title
-----------------
A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: OPAL Sound Processing Strategy.
* Device: OPAL-EM
* Device: SPACE
* Device: FAST
* Device: OPAL-SPACE
* Device: FAST-OPAL
* Device: Cochlear Device Interface Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPAL Sound Processing Strategy<br>OPAL Sound Processing Strategy with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: OPAL Sound Processing Strategy.<br>* OPAL Sound Processing Strategy. OPAL sound processing strategy designed to improve perception of fundamental frequency (F0) as cue to lexical tone in tonal languages and to pitch in music. This research strategy will be implemented in the Nucleus 6 CP900 sound processors. The programming will be performed by the investigational software Cochlear Device Interface Tool (CDI Tool). Investigational firmware will be written on a commercially available N6 sound processor sound processor.<br>Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|
| Experimental: OPAL-EM<br>OPAL-Enhanced Modulation with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: OPAL-EM<br>* OPAL-EM (Enhanced Modulation) is a version of OPAL that improves temporal accuracy in the coding of F0 amplitude-modulation in the stimulus envelope. It is specifically designed to address the need for use of low stimulation rates (i.e., lower than the recommended OPAL rate of around 1200 pps/ch) but it is also expected to provided improvements for all stimulation rates by virtue of the improved temporal accuracy it provides.<br>* Other names: OPAL Enhanced Modulation;Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|
| Experimental: SPACE<br>Spread Precompensation Advanced Combination Encoder (SPACE) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: SPACE<br>* 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.<br>* Other names: Spread Precompensation Advanced Combination Encoder;Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|
| Experimental: FAST<br>Fundamental Asynchronous Stimulus Timing (FAST) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: FAST<br>* FAST (Fundamental Asynchronous Stimulus Timing) is a low- and variable-rate coding strategy that has been shown to be power efficient and significantly increase sensitivity to ITD cues in bilateral subjects. It also explicitly codes low F0s as the rate of stimulation and may have tone and music benefits. It has been implemented on the Nucleus 5 CP800 sound processor for CIC4-based implants.<br>* Other names: Fundamental Asynchronous Stimulus Timing;Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|
| Experimental: OPAL-SPACE<br>OPAL-SPACE (combined OPAL and SPACE strategy) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: OPAL-SPACE<br>* 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.<br>Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|
| Experimental: FAST-OPAL<br>FAST-OPAL (combined FAST and OPAL strategy) with programming being performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). | Device: FAST-OPAL<br>* FAST-OPAL (combined FAST and OPAL strategy) strategy was developed to improve FAST strategy performance in noisy environments. The processing techniques employed by FAST-OPAL retain the sparse, yet temporally precise coding of temporal envelope information, while improving coding of that information in noise and coding of relative across-channel intensity in noise.<br>Device: Cochlear Device Interface Tool<br>* 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.<br>* Other names: CDI Tool;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | One Day |