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Preference Comparisons for Algorithms to Hear Speech

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
hearing aid -novel program
hearing aid - standard program
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Western UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hearing Aid use for listening to speech in a common difficult situation

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall preference for a specific microphone setting/configuration
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')

Secondary Outcome Measures

Rating of awareness of background noise
Scale from 0-100 with descriptors ('not at all' to 'extremely aware')
Rating of Listening effort
Scale from 1 - 7 with descriptors ('not at all' to 'very')
Rating of annoyance of artefacts
Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')

Full Information

First Posted
September 27, 2022
Last Updated
September 6, 2023
Sponsor
Sonova AG
Collaborators
Western University
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1. Study Identification

Unique Protocol Identification Number
NCT05561335
Brief Title
Preference Comparisons for Algorithms to Hear Speech
Official Title
Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Western University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid use for listening to speech in a common difficult situation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
hearing aid -novel program
Intervention Description
novel microphone configuration
Intervention Type
Device
Intervention Name(s)
hearing aid - standard program
Intervention Description
standard microphone configuration
Primary Outcome Measure Information:
Title
Overall preference for a specific microphone setting/configuration
Description
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Rating of awareness of background noise
Description
Scale from 0-100 with descriptors ('not at all' to 'extremely aware')
Time Frame
20 minutes
Title
Rating of Listening effort
Description
Scale from 1 - 7 with descriptors ('not at all' to 'very')
Time Frame
20 minutes
Title
Rating of annoyance of artefacts
Description
Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects fulfilling all of the following inclusion criteria are eligible for the investigation: Including adults with sensorineural mild to moderate-severe hearing loss hearing aid experience (greater than 6 months) who are able to complete the task in English. Language: Can speak and understand English Fluently Hearing loss within the fitting ranges of the investigational products. Healthy outer ear. Ability to understand instructions. Ability to describe listening experiences. Ability to fill out questionnaires. Informed consent as documented by signature. Exclusion Criteria: - The presence of any one of the following exclusion criteria will lead to the exclusion of the subject: Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product). Limited mobility and not able to attend to appointments or not able to go in a car. Reported symptoms of vertigo and dizziness by subject. Severe Tinnitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Don Hayes, PhD
Phone
519 500 3618
Email
don.hayes@unitron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Scollie, PhD
Organizational Affiliation
Western University (aka The University of Western Ontario)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 1G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Folkeard, AuD
Phone
519-661-2111
Ext
88936
Email
folkeard@nca.uwo.ca

12. IPD Sharing Statement

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Preference Comparisons for Algorithms to Hear Speech

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