Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-29 @ 10:58 AM
Study NCT ID:
NCT07156461
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients
Sponsor:
Cochlear
Organization:
Study Overview
Official Title:
A Pivotal, Interventional, Prospective, Multi-centre Clinical Investigation of Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients With Mixed Hearing Loss, Conductive Hearing Loss or Single-Sided Deafness
Status:
RECRUITING
Status Verified Date:
2025-09
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:
SONUS
Brief Summary:
The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness.
The main questions this study aims to answer are:
* Do the findings confirm the clinical performance of the Osia 3 Sound Processor?
* Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor?
Participants will:
* Undergo speech performance testing in both quiet and noisy environments
* Provide ratings for a self-reported questionnaire
The main questions this study aims to answer are:
* Do the findings confirm the clinical performance of the Osia 3 Sound Processor?
* Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor?
Participants will:
* Undergo speech performance testing in both quiet and noisy environments
* Provide ratings for a self-reported questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: