Preference Comparisons for Algorithms to Hear Speech

Sponsor
Sonova AG (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05561335
Collaborator
Western University (Other)
20
1
1
30
20.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: hearing aid -novel program
  • Device: hearing aid - standard program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hearing Aid use for listening to speech in a common difficult situation

The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.

Device: hearing aid -novel program
novel microphone configuration

Device: hearing aid - standard program
standard microphone configuration

Outcome Measures

Primary Outcome Measures

  1. Overall preference for a specific microphone setting/configuration [20 minutes]

    Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')

Secondary Outcome Measures

  1. Rating of awareness of background noise [20 minutes]

    Scale from 0-100 with descriptors ('not at all' to 'extremely aware')

  2. Rating of Listening effort [20 minutes]

    Scale from 1 - 7 with descriptors ('not at all' to 'very')

  3. Rating of annoyance of artefacts [20 minutes]

    Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • hearing aid user with more than 6 months of experience

  • can speak and understand English fluently

Exclusion Criteria:
  • contradictions to the medical device in this study (e.g., known hypersensitivity or allergy to the investigational product)

  • limited mobility and not able to attend appointments

  • reported symptoms of vertigo and/or dizziness

  • severe tinnitus

  • limited finger dexterity and unable to operate push buttons on hearing aid or remote control

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western University London Ontario Canada N6G 1G9

Sponsors and Collaborators

  • Sonova AG
  • Western University

Investigators

  • Principal Investigator: Susan Scollie, PhD, Western University (aka The University of Western Ontario)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05561335
Other Study ID Numbers:
  • 5251
First Posted:
Sep 30, 2022
Last Update Posted:
Sep 30, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2022