MED-EL Remote Care Multi-Center Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- Remote Care Completion
研究概览
简要总结
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.
详细描述
This prospective multicenter study will include MED-EL cochlear implant users from the US and Canada. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Inability or unwillingness to perform the requirements of the clinical investigation
- •Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
- •Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator
研究组 & 干预措施
Remote cochlear implant support
Participants will use MED-EL Remote Care to test their hearing and device functionality. Participants and clinicians will complete user feedback surveys regarding their experience and time/cost-savings.
干预措施: MED-EL Remote Care (Device)
结局指标
主要结局
Remote Care Completion
时间窗: Up to 6 months post-training
Number and proportion of fully completed Remote Care visits.
次要结局
- Patient time savings(Up to 6 months post-training)
- Patient cost estimates(Up to 6 months post-training)
- Clinician time savings(Up to 6 months post-training)
- Patient Feedback Survey(Up to 6 months post-training)
- Clinician Feedback Survey(Mid-enrollment to enrollment completion)
- Remote hearing assessments(Up to 6 months post-training)