Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543953
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Remote Support for Cochlear Implant Recipients Evaluation of the HearCare MED-EL App
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Remote Support for Cochlear Implant Recipients Evaluation of the HearCare MED-EL App
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCARE
Brief Summary:
This clinical investigation intends to assess safety and performance of the HearCare MED-EL App a remote care option for recipients of MED-EL cochlear implants
Detailed Description:
Remote care solutions can provide cochlear implant users a greater convenience accessibility and personalized care These advantages stem from the ability to fine-tune and adjust their devices from the comfort of their own environments without the need for frequent and time-consuming in-person clinic visits
Remote care allows clinicians to remotely assess data provide guidance and make necessary adjustments all while minimizing the need for physical presence This streamlined approach translates to increased capacity for serving a larger number of patients ultimately leading to improved patient outcomes
The HearCare MED-EL App is a mobile smartphone application designed for recipients of at least one compatible MED-EL cochlear implant and respective audio processor The app manages technical checks on compatible cochlear implants and audio processors creates and utilizes backups of audio processor configurations and performs updates of audio processor configurations by acting as an executive organ of the MAESTRO System Software The app reduces face-to-face follow-up appointments of userscaregivers with hearing professionals while maintaining safe and ongoing care for all individuals
This clinical investigation aims to evaluate the HearCare MED-EL App regarding safety and performance
Remote care allows clinicians to remotely assess data provide guidance and make necessary adjustments all while minimizing the need for physical presence This streamlined approach translates to increased capacity for serving a larger number of patients ultimately leading to improved patient outcomes
The HearCare MED-EL App is a mobile smartphone application designed for recipients of at least one compatible MED-EL cochlear implant and respective audio processor The app manages technical checks on compatible cochlear implants and audio processors creates and utilizes backups of audio processor configurations and performs updates of audio processor configurations by acting as an executive organ of the MAESTRO System Software The app reduces face-to-face follow-up appointments of userscaregivers with hearing professionals while maintaining safe and ongoing care for all individuals
This clinical investigation aims to evaluate the HearCare MED-EL App regarding safety and performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None