Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07213505
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Organization:
Study Overview
Official Title:
Investigating New Front-end Features in the SONNET 3
Status:
RECRUITING
Status Verified Date:
2025-11
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:
M11S3
Brief Summary:
Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear. While they significantly improve speech perception in quiet environments and over the telephone, challenges remain in noisy environments due to interference from background noise. To address this, advancements in signal-processing strategies, microphone technology, and noise-reduction algorithms have been introduced.
The focus of the study is on two new front-end features:
* Focused Beamformer - Enhances directional hearing.
* AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.
The focus of the study is on two new front-end features:
* Focused Beamformer - Enhances directional hearing.
* AI Mode Medium - Utilizes the adaptive intelligence for optimized sound processing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: