At a glance
ClinicalIndex Comparison Record- ✓Users of a CE approved Nucleus cochlear implant with open set speech understanding
- ✓Paediatric participants: age >5 and <18 years (Belgium only)
- ✓Adult participants: age ≥18 years (Belgium and Australia)
- ✓Fluent speaker in the language used for assessments (subject or legally designated representative)
- ✕Unable or unwilling to comply with clinical investigation requirements
- ✕Additional health factors that would prevent or restrict participation in audiological evaluations
- ✕Investigator site personnel or their immediate families
- ✕Cochlear employees or employees of Contract Research Organisations engaged by Cochlear
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating SPACE, OPAL-SPACE, and 2 other interventions for Hearing Loss. Completed, enrolled 8 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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 (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.
Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.
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.