Hearing AidsRCTNCT04840277
Remote Hearing Aid Adjustment for Experienced Hearing Aid Users
A study testing Remote hearing aid adjustment in people with Hearing Aids, run by Sodra Alvsborgs Hospital at 1 site in Sweden.
Trial summary
Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Aids
- What is being tested?
- Remote hearing aid adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 31 May 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
- >18 yr of age
- experienced hearing aid user
Who cannot join
- <18 yr of age
- new hearing aid users
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hearing Clinic, Hearing Organization
Borås, Vastra Gotalandsregion, 501 82
About this study
Official title: Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial
Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.
The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.
- Conditions
- Hearing Aids
- Being tested
- Remote hearing aid adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote hearing aid adjustmentDevice
The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely. Receives: Device: Remote hearing aid adjustment |
| Control group | No intervention | Traditional hearing aid adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)
Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome.
Measured: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
Secondary outcomes (1)
The Abbreviated Profile of Hearing Aid Benefit (APHAB)
Measures subjective hearing loss in four typical hearing situations; minimum
Measured: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Mar 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing AidsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodra Alvsborgs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milijana Malmberg, Sodra Alvsborgs Hospital
- Investigators
- Milijana Malmberg, PhD, Principal investigator, Hearing Organization, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840277
- Sponsor's protocol ID
- Remote HA-fitting
- Acronym
- RCT
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malmberg M, Hagberg J. Synchronous remote fine-tuning and follow-up within aural rehabilitation: a randomised controlled trial. Int J Audiol. 2024 Jun;63(6):458-466. doi: 10.1080/14992027.2023.2188437. Epub 2023 Mar 27.
PubMed 36971711
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04840277
- Acronym / sponsor ID
- RCT / Remote HA-fitting
- Conditions
- Hearing Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sodra Alvsborgs HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 9 Apr 2021 (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.
Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist.
The purpose of this project is to offer remote hearing aid adjustment as an additional support for experienced hearing aid users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Remote hearing aid adjustmentRemote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely. |
| Control group | No intervention | –Traditional hearing aid adjustment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 yr of age
- experienced hearing aid user
Key exclusion criteria (2 listed)
- <18 yr of age
- new hearing aid users
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 |
|---|---|---|
| Remote hearing aid adjustmentThe intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones. | Device | Intervention group |
Primary outcome
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)
Time frame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome.
1 secondary outcome
The Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post
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 3 Nov 2022.
- Derived from this study: PubMed 36971711Malmberg M, Hagberg J. Synchronous remote fine-tuning and follow-up within aural rehabilitation: a randomised controlled trial. Int J Audiol. 2024 Jun;63(6):458-466. doi: 10.1080/14992027.2023.2188437. Epub 2023 Mar 27.
- 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.
Milijana Malmberg, PhD principal investigator
Hearing Organization, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote hearing aid adjustment in people with Hearing Aids, run by Sodra Alvsborgs Hospital at 1 site in Sweden.
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 2 inclusion and 2 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 3 Nov 2022. 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 Sweden. 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?
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A) (time frame: Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840277, which also lists 1 linked publication.
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 3 Nov 2022; AzTrials last refreshed its copy on 2 Nov 2026.