At a glance
ClinicalIndex Comparison Record- ✓Current user of a CE approved Nucleus cochlear implant with open set speech understanding
- ✓At least 3 months experience with the cochlear implant
- ✓Age older than 18 years
- ✓Fluent speaker in the language used for study assessments
- ✕Unable or unwilling to comply with study requirements
- ✕Additional health factors that would prevent or restrict participation in audiological evaluations
- ✕Investigator site personnel or their immediate family members
- ✕Cochlear employees or employees of Contract Research Organizations engaged for this investigation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation
In Brief
A clinical study evaluating Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique for Hearing Loss. Completed, enrolled 20 participants across 5 sites in 2 countries.
Detailed Summary
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.
Study Details
Timeline
Interventions
The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.