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Preliminary feasibility outcomes from 4 enrolled participants met expectations. Following a serious adverse event that is unrelated to the investigational device/procedures, a risk-benefit assessment determined additional enrolment was not justified.
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The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
Following Cochlear's acquisition of Neurelec, there is a need to support existing NeuroZti implant users who currently rely on the Neuro 2 sound processor. The Nuc8-based sound processor, currently in development, is designed to be compatible with the Neuro system while integrating with Cochlear's ecosystem of tools and applications developed over the past decade.
To ensure long-term support and maintainability, transitioning to the Nuc8 sound path is preferred. However, changes in sound paths may impact sound quality, speech perception, and user acceptance.
The main question this study aims to answer is: how does speech performance and user satisfaction compare between the Nuc8 and Neu2 sound paths?
Participants will:
The study involves a single visit lasting approximately 3 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sound paths in NeuroZti cochlear implant users | Experimental | NeuroZti cochlear implant users will complete speech perception testing and rate comfort and satisfaction between the Nuc8 and Neu2 sound paths. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMRP R2 + Percepolis Accessory Software | Device | The Oticon Medical Research Platform Release 2 (OMRP R2) + Percepolis Accessory Software is an investigational or research tool that includes hardware, firmware and software elements, which can connect to an Oticon Medical Cochlear Implant (CI). It is intended to be used exclusively for research with Oticon Medical CI users participating in research experiments or clinical studies. The hardware components are referred to as 'OMRP R2' and the software components are called 'Percepolis Accessory Software'. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage disyllabic word recognition Fournier scores in quiet at stimulated input level of 65 dB SPL for both Nuc8 and Neu2 sound paths | This involves testing open-set speech perception performance at simulated input of 65 dB SPL, which represents speech spoken at a normal conversational level. The word test will be performed in the sound field at 0° azimuth. Upon hearing the word, participants are instructed to repeat back the word, and the experimenter will score the recognition correct as either correct (i.e., when the subject repeat the exact word) or incorrect (i.e., when the subject does not repeat the exact word). | Day 0 (Study Visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage disyllabic word recognition scores in quiet at stimulated input level of 55 dB SPL and at 40 dB SPL for both Nuc8 and Neu2 sound paths | This involves testing softer levels of 55 dB SPL and 40 dB SPL to investigate differences in speech coding and dynamic range management system over a range of levels. | Day 0 (Study Visit 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PRS Specialist | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cochlear Vallauris | Vallauris | 06220 | France |
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| Nuc8 Sound Path | Device | Nuc8 is the sound path used in Cochlear Nucleus Sound Processors. |
|
| Neu2 Sound Path | Device | Neu2 is the sound path that is currently used in the Neuro 2 Sound Processor. |
|
| Occurrence rate of preference using Neu2 and Nuc8 configurations for four subjective preference questions |
This outcome measure involves a comparison of subjective comfort and satisfaction with Neu2 versus Nuc8 sound paths. Participants will judge the quality and comfort of various sounds that are presented, answering four questions: Q1: Which one sounds louder? Q2: Which one sounds clearer? Q3: Which one sounds more pleasant? Q4: Which one do you prefer listening to everyday in your behind the ear sound processor? |
| Day 0 (Study Visit 1) |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |