Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-06 @ 6:07 AM
Study NCT ID:
NCT02042404
Status:
COMPLETED
Last Update Posted:
2016-02-02
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Sponsor:
EarLens Corporation
Organization:
Study Overview
Official Title:
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Status:
COMPLETED
Status Verified Date:
2016-01
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:
The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: