MED-EL Remote Care Multi-Center Feasibility Study
A legfontosabb adatok
- Hol
- Ann Arbor, Chapel Hill és Iowa City (Egyesült Államok)Mind a 3 helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of MichiganAnn Arbor, Egyesült ÁllamokNo longer taking part
- University of North CarolinaChapel Hill, Egyesült ÁllamokNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Med-El Corporation
- Azonosító
- NCT05973669
- A regiszteradat frissítve
- 2026. július 31.
- Eredeti leírás
MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.A teljes eredeti leírásKevesebb
MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
Bevonási feltételek: Implanted with at least one MED-EL cochlear implant; ≥ 2 weeks since activation of the cochlear implant; Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline; Utilizing a compatible audio processor in the SONNET or RONDO product lines; Ability to complete app-based hearing assessments; Commitment to comply with all study procedures for the duration of the study; Access to the internet via a smartphone that meets the following requirements:; Android or iOS operating systems; A smartphone supporting Bluetooth® 4.2 or higher; A minimum of 200 MB free storage space.
Kizáró feltételek: Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care; Inability or unwillingness to perform the requirements of the clinical investigation; Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator.