Trials / Completed
CompletedNCT02644343
Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
Detailed description
Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Custom Sound | Custom Sound is the programming software used to program Nucleus cochlear implants. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-05-17
- Completion
- 2017-05-17
- First posted
- 2015-12-31
- Last updated
- 2020-11-24
- Results posted
- 2020-11-10
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02644343. Inclusion in this directory is not an endorsement.