Cochlear Implant, Cochlear Implant Recipients, Cochlear Implants, Hearing Disorders, Hearing Loss, Sensorineural
Conditions
Keywords
cochlear implants, telehealth, remote care
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMED-EL Remote Care
Remote cochlear implant support
Sponsors
Med-El Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remote Care Completion | Up to 6 months post-training | Number and proportion of fully completed Remote Care visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient time savings | Up to 6 months post-training | Average time estimates associated with attending an in-clinic appointment compared to Remote Care completion time. |
| Patient cost estimates | Up to 6 months post-training | Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment. |
| Clinician time savings | Up to 6 months post-training | Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time. |
| Patient Feedback Survey | Up to 6 months post-training | Subject satisfaction measured using a custom questionnaire administered after each use of Remote Care. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction. |
| Clinician Feedback Survey | Mid-enrollment to enrollment completion | Clinician satisfaction measured using a custom questionnaire administered at mid-enrollment and at study completion. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction. |
| Remote hearing assessments | Up to 6 months post-training | Average remote hearing assessment results compared to standard aided test results obtained at baseline. |
Countries
Canada, United States
Outcome results
None listed