Anatomy-based Fitting in Cochear Implant Users
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.
| Condition(s) | Cochlear Implant, Outcomes, Quality of Life |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes. |
| Who can participate | Inclusion Criteria: * Age ≥ 18 years * Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * Post-OP CT scan of the CI electrode available * Subject implanted with MED-EL cochlear implant(s) * Subjects received a Flex28 or FlexSoft electrode * Subject planned to receive a SONNET 2 /RONDO3 audio processor on the newly implanted side * Audio processor not yet activated on the newly implanted side * The most apical active electrode contact has to be inserted at least 450° * Minimum of 10 active channels can be activated * Fluent in Spanish * Signed and dated ICF before the start of any study-specific procedure Specific inclusion criteria for the possible study groups • Bilateral CI users: Bilateral CI implantation SONNET 2/RONDO3 audio processor on the |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz |
| Locations | Madrid, Madrid, Spain |
| Start date | 2022-03-11 |
| NCT ID | NCT05360212 |
| Official listing | https://clinicaltrials.gov/study/NCT05360212 |