Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2026-02-18 @ 12:59 AM
Study NCT ID:
NCT02772757
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Status:
COMPLETED
Status Verified Date:
2019-02
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 overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.
Detailed Description:
This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.
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?: