Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT05292534
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Sponsor:
Sonova AG
Organization:
Study Overview
Official Title:
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.
Detailed Description:
2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: