Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774185
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2021-02-25
Brief Title:
Hearing Aid Transmitter Performance Study - SRF-366
Sponsor:
Sonova AG
Organization:
Sonova AG
Study Overview
Official Title:
Hearing Aid Transmitter Performance Study - SRF-366
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Sonova Hearing Systems pass through different development and study stages At an early stage feasibility studies are conducted to investigate new algorithms features and functions in an isolated manner If the benefit is proven their performance is then investigated regarding interdependency between all available algorithms features and functions running in parallel in a hearing aid pivotalpre-validation studies and as a result they get optimized Afterwards and prior to product launch the Sonova Hearing Systems undergo a final quality control in terms of clinical trials This is a confirmatory study investigating benefits of a modified hearing aid loudspeaker This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience Australia
Detailed Description:
In this study a comparison with two Phonak Receiver in Canal RIC devices is done The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility listening effort and sound quality in speech in noise quiet situations for people with mild to moderate hearing losses
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None