Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04918654
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2021-05-31
Brief Title:
Automatic Sound Management 30 in a Single-unit Audio Processor
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
MED-EL Elektromedizinische Geräte GesmbH
Study Overview
Official Title:
Automatic Sound Management 30 in a Single-unit Audio Processor
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RND3
Brief Summary:
Cochlear implants are routine treatment for people with severe hearing loss This study tests the RONDO 3 MED-ELs newest single-unit audio processor which comes with new features Beamformer Wind-Noise reduction Ambient noise reduction Transient noise reduction Adaptive intelligence
Detailed Description:
MED-EL Cochlear Implants CI provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition Front-end processing of acoustic signals picked up by the audio processor is routinely applied to provide optimal hearing performance under varying listening conditions Automatic Sound Management ASM was introduced by MED-EL with the TEMPO audio processor and provided advanced compression and automatic gain management With the SONNET audio processor MED-EL introduced ASM 20 which added wind noise reduction and microphone directionality to the front-end processing With the SONNET 2 audio processor ASM 30 was implemented and the features ambient noise reduction transient noise reduction and an adaptive intelligence AI were added The RONDO 3 implements now ASM 30
This study investigates the impact of ASM 30 as implemented in the RONDO 3 on CI users speech performance and their subjective quality of hearing
This study investigates the impact of ASM 30 as implemented in the RONDO 3 on CI users speech performance and their subjective quality of hearing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None