Hearing LossNCT05280808
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
A study testing Experimental phone app used for self-fitting of hearing aids in people with Hearing Loss, run by Sonova AG at 1 site in Australia.
Trial summary
The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Experimental phone app used for self-fitting of hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Mar 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Dexterity or cognitive issues that would be problematic for using the app in the study
Trial locations and contacts
1 site in 1 country.
Australia1 site
Melbourne Support Office and Clinic/Teleaudiology
Carlton, Victoria, 3053
About this study
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
The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Experimental phone app used for self-fitting of hearing aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental phone app used for self-fitting of hearing aidsDevice
This software allows participants to set up hearing aids as appropriate for their hearing loss
| Study group | Role | What they receive |
|---|---|---|
| Experimental phone app | Experimental | Experimental phone app for self-fitting of hearing aids Receives: Device: Experimental phone app used for self-fitting of hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1, Day 10, Day 20 and Day 30.
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.
Measured: Days 1-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start18 Mar 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sonova Audiological Care Australia Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Justin A Zakis, PhD, Principal investigator, Sonova Audiological Care Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280808
- Sponsor's protocol ID
- SRF-385
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05280808
- Acronym / sponsor ID
- SRF-385
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Sonova Audiological Care Australia Pty Ltd
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental phone app | Experimental | Device: Experimental phone app used for self-fitting of hearing aidsExperimental phone app for self-fitting of hearing aids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Online client
- Daily aid use
- Bilateral aid use
- Uses P70-R or P90-R aids (same model both ears)
- Does not use earmolds
Key exclusion criteria (1 listed)
- Dexterity or cognitive issues that would be problematic for using the app in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental phone app used for self-fitting of hearing aidsThis software allows participants to set up hearing aids as appropriate for their hearing loss | Device | Experimental phone app |
Primary outcome
Change in speech perception after 30 days
Time frame: Day 1 and Day 30
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
Time frame: Day 1 and Day 30
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
Time frame: Day 1
The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.
2 secondary outcomes
Change in preferences for fitted settings and fitting method over 30 days
Time frame: Day 1, Day 10, Day 20 and Day 30.
Change in experimental self-fitting phone app use over 30 days
Time frame: Days 1-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin A Zakis, PhD principal investigator
Sonova Audiological Care Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental phone app used for self-fitting of hearing aids in people with Hearing Loss, run by Sonova AG at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speech perception after 30 days (time frame: Day 1 and Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.