Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
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
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2022
CompletedFebruary 6, 2023
February 1, 2022
9 months
February 23, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Day 1 and Day 30
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.
Day 1 and Day 30
Softest sounds that can be heard
The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.
Day 1
Secondary Outcomes (2)
Change in preferences for fitted settings and fitting method over 30 days
Day 1, Day 10, Day 20 and Day 30.
Change in experimental self-fitting phone app use over 30 days
Days 1-30
Study Arms (1)
Experimental phone app
EXPERIMENTALExperimental phone app for self-fitting of hearing aids
Interventions
This software allows participants to set up hearing aids as appropriate for their hearing loss
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dexterity or cognitive issues that would be problematic for using the app in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
- Sonova Audiological Care Australia Pty Ltdcollaborator
Study Sites (1)
Melbourne Support Office and Clinic/Teleaudiology
Carlton, Victoria, 3053, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin A Zakis, PhD
Sonova Audiological Care Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 15, 2022
Study Start
March 18, 2022
Primary Completion
November 29, 2022
Study Completion
November 29, 2022
Last Updated
February 6, 2023
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share