Hearing AidsRCTNCT04843124
Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)
A study testing Remote HA adjustment and Traditional hearing aid 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 HA adjustment and Traditional hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to 30 Aug 2023
- 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
- new hearing aid user
Who cannot join
- <18 yr of age
- experienced 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 New 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 new hearing aid users.
- Conditions
- Hearing Aids
- Being tested
- Remote HA adjustment, Traditional hearing aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote HA 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.
Traditional hearing aidOther
Traditional hearing aid
| 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 HA adjustment |
| Control group | Active comparator | Traditional hearing aid adjustment Receives: Other: Traditional hearing aid |
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 (subscales). There are six items for each subscale. Each item is answered for "without my hearing aid" and "with my hearing aid". Each item is a statement associated with a percentage of occasions (1%_Never, 12%_Seldom, 25%_Occasionally, 50%_Half-the-time, 75%_Generally, 87%_Almost Always, 99%_Always)
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 posted13 Apr 2021
- Study start1 Feb 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 69 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843124
- Sponsor's protocol ID
- Remote HA-fitting new
- Acronym
- RCT
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04843124
- Acronym / sponsor ID
- RCT / Remote HA-fitting new
- Conditions
- Hearing Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sodra Alvsborgs HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 13 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 new 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 HA adjustmentRemote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely. |
| Control group | Active comparator | Other: Traditional hearing aidTraditional 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
- new hearing aid user
Key exclusion criteria (2 listed)
- <18 yr of age
- experienced 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 HA 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 |
| Traditional hearing aidTraditional hearing aid | Other | Control 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 29 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 HA adjustment and Traditional hearing aid 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 29 Nov 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 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?
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 29 Nov 2023.