Trials / Completed
CompletedNCT05709223
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
Detailed description
Firstly, it aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. Secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Categorical loudness scaling based fitting using the Nexus Research System. | The Nexus Research system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. It is also intended to be used with other devices of a hearing implant system to make volume adjustments to the processing unit, to download pre-defined MAPs and to collect data from tests and questionnaires using a compatible device. |
| DEVICE | Behavioural fitting using Custom Sound Suite (CSS 6.3) Software | The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software |
Timeline
- Start date
- 2023-03-14
- Primary completion
- 2025-02-26
- Completion
- 2025-02-26
- First posted
- 2023-02-02
- Last updated
- 2025-04-17
Locations
4 sites across 3 countries: United States, Australia, Germany
Source: ClinicalTrials.gov record NCT05709223. Inclusion in this directory is not an endorsement.