Back to resultsEvaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Experimental phone app used for self-fitting of hearing aids
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Online client
- Daily aid use
- Bilateral aid use
- Uses P70-R or P90-R aids (same model both ears)
- Does not use earmolds
- Uses same soft tip on both aids
- Owns iPhone7/iOS12 or later
- Willing to install prototype app on own phone and use it in study
- Willing to participate in study for 30 days
Exclusion Criteria:
- Dexterity or cognitive issues that would be problematic for using the app in the study
Sites / Locations
- Melbourne Support Office and Clinic/Teleaudiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental phone app
Arm Description
Experimental phone app for self-fitting of hearing aids
Outcomes
Primary Outcome Measures
Change in speech perception after 30 days
The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception.
Change in self-rated hearing ability after 30 days
An expanded version of the Client Oriented Scale of Improvement questionnaire will be used to assess the effect of the intervention on self-rated hearing ability in different listening situations.
Softest sounds that can be heard
The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.
Secondary Outcome Measures
Change in preferences for fitted settings and fitting method over 30 days
A custom questionnaire will be used to assess preferences for the fitted settings and fitting method of the intervention as these preferences evolve over time.
Change in experimental self-fitting phone app use over 30 days
The use of the experimental self-fitting phone app will be automatically logged every day to assess changes in how the app is used over time.
Full Information
NCT ID
NCT05280808
First Posted
February 23, 2022
Last Updated
February 3, 2023
Sponsor
Sonova AG
Collaborators
Sonova Audiological Care Australia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05280808
Brief Title
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
Official Title
Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sonova Audiological Care Australia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.
Detailed Description
After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.
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
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental phone app
Arm Type
Experimental
Arm Description
Experimental phone app for self-fitting of hearing aids
Intervention Type
Device
Intervention Name(s)
Experimental phone app used for self-fitting of hearing aids
Intervention Description
This software allows participants to set up hearing aids as appropriate for their hearing loss
Primary Outcome Measure Information:
Title
Change in speech perception after 30 days
Description
The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception.
Time Frame
Day 1 and Day 30
Title
Change in self-rated hearing ability after 30 days
Description
An expanded version of the Client Oriented Scale of Improvement questionnaire will be used to assess the effect of the intervention on self-rated hearing ability in different listening situations.
Time Frame
Day 1 and Day 30
Title
Softest sounds that can be heard
Description
The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Change in preferences for fitted settings and fitting method over 30 days
Description
A custom questionnaire will be used to assess preferences for the fitted settings and fitting method of the intervention as these preferences evolve over time.
Time Frame
Day 1, Day 10, Day 20 and Day 30.
Title
Change in experimental self-fitting phone app use over 30 days
Description
The use of the experimental self-fitting phone app will be automatically logged every day to assess changes in how the app is used over time.
Time Frame
Days 1-30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Online client
Daily aid use
Bilateral aid use
Uses P70-R or P90-R aids (same model both ears)
Does not use earmolds
Uses same soft tip on both aids
Owns iPhone7/iOS12 or later
Willing to install prototype app on own phone and use it in study
Willing to participate in study for 30 days
Exclusion Criteria:
Dexterity or cognitive issues that would be problematic for using the app in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin A Zakis, PhD
Organizational Affiliation
Sonova Audiological Care Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melbourne Support Office and Clinic/Teleaudiology
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
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