Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723173
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-01-22
Brief Title:
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Sponsor:
Sonova AG
Organization:
Sonova AG
Study Overview
Official Title:
Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Phonak 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 Phonak Hearing Systems undergo a final quality control in terms of clinical trials This is a pre-validation study investigating optimized algorithms features functions and wearing comfort This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa Switzerland
Detailed Description:
The study will compare different features of the Phonak behind the ear device activated and deactivated for example the noise reduction feature There shall be differences in listening effort awareness and sound quality shown The study shall show the advantages especially for people with severe to profound hearing losses This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa Switzerland
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