Hearing LossNCT06051968
Effects of an Online Hearing Support for First-time Hearing Aid Users
A study testing Online hearing support for first-time hearing aid users and Hearing rehabilitation according to common practice. in people with Hearing Loss and Hearing Impairment, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hearing Loss, Hearing Impairment, Hearing Disorders
- What is being tested?
- Online hearing support for first-time hearing aid users and Hearing rehabilitation according to common practice.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSweden
- Study dates
- 18 Sep 2023to 7 Apr 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > 20 years of age that are eligible for hearing aids
- Access to a computer, tablet and/or smartphone with internet
- Access to a Swedish BankID or equivalent
Who cannot join
- Inability to read and understand Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.
- Conditions
- Hearing Loss, Hearing Impairment, Hearing Disorders, Hearing Disability, Ear Diseases, Sensation Disorders
- Being tested
- Online hearing support for first-time hearing aid users, Hearing rehabilitation according to common practice.
- Medical subject headings
- Hearing Loss, Hearing Disorders, Ear Diseases, Sensation Disorders, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online hearing support for first-time hearing aid usersBehavioural
Also called Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabilitering
Participants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic.
Hearing rehabilitation according to common practice.Behavioural
Participants get hearing rehabilitation according to common practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants get hearing rehabilitation according to common practice and the online hearing support. Receives: Behavioral: Online hearing support for first-time hearing aid users |
| Control group | Active comparator | Participants get hearing rehabilitation according to common practice. Receives: Behavioral: Hearing rehabilitation according to common practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hearing Handicap Inventory for the Elderly (HHIE)
Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.
Measured: Baseline, directly post intervention and 6 months post intervention.
Secondary outcomes (3)
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.
Measured: Baseline, directly post intervention and 6 months post intervention.
Communication Strategies Scale (CSS)
Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.
Measured: Baseline, directly post intervention and 6 months post intervention.
The International Outcome Inventory for Hearing Aids (IOI-HA)
Assessing changes in perceived effectiveness and satisfaction with hearing aids.
Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.
Measured: Directly post intervention and 6 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start18 Sep 2023
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
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.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Horselvarden Region Ostergotland
- Responsible party
- Sponsor
- Investigators
- Marie Öberg, Principal investigator, Horselvarden Region Ostergotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051968
- Sponsor's protocol ID
- 2023-01633-02
- Other IDs
- 2023
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06051968
- Acronym / sponsor ID
- 2023-01633-02
- Conditions
- Hearing Loss, Hearing Impairment, Hearing Disorders, Hearing Disability, Ear Diseases, Sensation Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Horselvarden Region Ostergotland
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 25 Sep 2023 (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 goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Online hearing support for first-time hearing aid usersParticipants get hearing rehabilitation according to common practice and the online hearing support. |
| Control group | Active comparator | Behavioral: Hearing rehabilitation according to common practice.Participants get hearing rehabilitation according to common practice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > 20 years of age that are eligible for hearing aids
- Access to a computer, tablet and/or smartphone with internet
- Access to a Swedish BankID or equivalent
Key exclusion criteria (1 listed)
- Inability to read and understand Swedish
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 |
|---|---|---|
| Online hearing support for first-time hearing aid usersAlso: Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabiliteringParticipants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic. | Behavioural | Intervention group |
| Hearing rehabilitation according to common practice.Participants get hearing rehabilitation according to common practice. | Behavioural | Control group |
Primary outcome
The Hearing Handicap Inventory for the Elderly (HHIE)
Time frame: Baseline, directly post intervention and 6 months post intervention.
Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.
3 secondary outcomes
The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)
Time frame: Baseline, directly post intervention and 6 months post intervention.
Communication Strategies Scale (CSS)
Time frame: Baseline, directly post intervention and 6 months post intervention.
The International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Directly post intervention and 6 months post intervention.
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 12 Aug 2026.
- 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.
Marie Öberg principal investigator
Horselvarden Region Ostergotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online hearing support for first-time hearing aid users and Hearing rehabilitation according to common practice. in people with Hearing Loss and Hearing Impairment, run by Region Skane 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 3 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 12 Aug 2026. 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?
The Hearing Handicap Inventory for the Elderly (HHIE) (time frame: Baseline, directly post intervention and 6 months post intervention.). 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 12 Aug 2026.