Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-06 @ 2:32 PM
Study NCT ID:
NCT02470494
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The EarLens Contact Hearing Device (CHD) Spectrum Study
Sponsor:
EarLens Corporation
Organization:
Study Overview
Official Title:
The EarLens Contact Hearing Device (CHD) Spectrum Study
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Spectrum
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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.
Detailed Description:
The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.
Study Oversight
Has Oversight DMC:
False
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?: