Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 10:14 AM
Study NCT ID:
NCT04374851
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
Sponsor:
Bernafon AG
Organization:
Study Overview
Official Title:
A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing Strategies and Their Effect on Speech Understanding
Status:
COMPLETED
Status Verified Date:
2021-01
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 purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices. Speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. There should be no artefacts or unwanted noises caused by the new system.
Detailed Description:
This is a controlled, double-blinded, comparative clinical evaluation conducted monocentric at the premised of Bernafon AG in Bern, Switzerland.
For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.
Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.
Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.
Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.
Safety Endpoint: The study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented DSP system before releasing it to the market.
For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.
Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.
Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.
Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.
Safety Endpoint: The study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented DSP system before releasing it to the market.
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?: