Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 6:43 AM
Study NCT ID:
NCT07252492
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2
Sponsor:
Archean Technologies
Organization:
Study Overview
Official Title:
Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking
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:
AUDIOCAP-2
Brief Summary:
The goal of this clinical trial is the evaluation of performances, clinical benefits and safety of the 'Audiocap' connected hearing rehabilitation device for improving audibility in hearing-impaired people.
The main question it aims to answer is to demonstrate, after one month's use of the Audiocap connected hearing aid, that the audiological gain for the patient is better than with a placebo hearing aid.
Placebo hearing aid is a Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid).
Participants will be first-time hearing aid users, eligible for hearing aid fitting, and adults according to French legislation (18 years and older).
The main question it aims to answer is to demonstrate, after one month's use of the Audiocap connected hearing aid, that the audiological gain for the patient is better than with a placebo hearing aid.
Placebo hearing aid is a Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid).
Participants will be first-time hearing aid users, eligible for hearing aid fitting, and adults according to French legislation (18 years and older).
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?:
False
Is an FDA AA801 Violation?: