Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-02 @ 1:44 AM
Study NCT ID:
NCT05067751
Status:
UNKNOWN
Last Update Posted:
2021-10-05
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymmetrical Directionality With Bimodal Systems.
Sponsor:
GN Hearing A/S
Organization:
Study Overview
Official Title:
Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
NOT_YET_RECRUITING
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:
Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.
Detailed Description:
The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.
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?: