Viewing Study NCT05561335


Ignite Creation Date: 2025-12-24 @ 10:45 PM
Ignite Modification Date: 2026-01-01 @ 6:03 PM
Study NCT ID: NCT05561335
Status: UNKNOWN
Last Update Posted: 2023-09-07
First Post: 2022-09-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Preference Comparisons for Algorithms to Hear Speech
Sponsor: Sonova AG
Organization:

Study Overview

Official Title: Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
Status: UNKNOWN
Status Verified Date: 2023-09
Last Known Status: 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: Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.
Detailed Description: People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.

This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.

Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.

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?: