Hearing LossNCT07255586
Self-monitoring of Hearing Aids Using Artificial Intelligence
A study testing Self-monitoring of hearing aids using artificial intelligence and Traditional hearing care at our clinics. in people with Hearing Loss, run by Sodra Alvsborgs Hospital at 1 site in Sweden.
Trial summary
This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Self-monitoring of hearing aids using artificial intelligence and Traditional hearing care at our clinics.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are eligible for a new or renewed hearing rehabilitation process at four of the Hearing organizations audiology clinics
Who cannot join
- Not fullfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care.
Read the detailed description
Considering the growing population, healthcare is increasingly focusing on integrating digital solutions into care. Such solutions typically require active patient participation and have the potential to positively impact person-centered care.
The purpose of this project is to investigate the outcomes of complementing physical and/or digital hearing care visits with patient self-monitoring of hearing aids. Participants will undergo the standard steps of the hearing rehabilitation process. In addition, the intervention group will be offered the opportunity to self-monitor their hearing aids between physical and/or digital appointments using artificial intelligence (AI) integrated into a mobile application provided by a hearing aid supplier.
The focus is to increase patient involvement in the rehabilitation process, utilize adjustment possibilities in everyday sound environments, and improve access to hearing care for the target population.
- Conditions
- Hearing Loss
- Being tested
- Self-monitoring of hearing aids using artificial intelligence, Traditional hearing care at our clinics.
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring of hearing aids using artificial intelligenceDevice
Self-monitoring of hearing aids using artificial intelligence
Traditional hearing care at our clinics.Other
Traditional hearing care at our clinics
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Self-monitoring of hearing aids. ALl participants in this group are offered self-monitoring of hearing aids. Receives: Device: Self-monitoring of hearing aids using artificial intelligence |
| Standard care | Other | All participants in this group are offered traditional hearing care. Receives: Other: Traditional hearing care at our clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly-Screening
Evaluates self-perceived psychosocial and emotional effects of hearing loss. Min 0 to max 100 points. Higher points equal greater self-perceived hearing problems.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Client Oriented Scale of Improvement
Not reporting score on a scale.
Measured: From enrollment to the end of treatment at 6 months
Communication Strategies Scale of the Communication Profile for the Hearing Impaired
The CSS includes three subscales: the Maladaptive Behaviours, nine questions addressing strategies that complicate communication, and Verbal Strategies and Nonverbal Strategies, both of which address 16 items related to strategies that can improve communication. The scoring for all three subscales reflects how frequently a specific strategy occurs in different situations.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
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 M Malmberg, PhD, Principal investigator, Habilitering & Hälsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255586
- Sponsor's protocol ID
- Self-monitoring of HAs
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2025
- Last updated
- 26 Oct 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-monitoring of Hearing Aids Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07255586
- Acronym / sponsor ID
- Self-monitoring of HAs
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sodra Alvsborgs HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 1 Dec 2025 (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.
This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care.
Detailed description
Considering the growing population, healthcare is increasingly focusing on integrating digital solutions into care. Such solutions typically require active patient participation and have the potential to positively impact person-centered care.
The purpose of this project is to investigate the outcomes of complementing physical and/or digital hearing care visits with patient self-monitoring of hearing aids. Participants will undergo the standard steps of the hearing rehabilitation process. In addition, the intervention group will be offered the opportunity to self-monitor their hearing aids between physical and/or digital appointments using artificial intelligence (AI) integrated into a mobile application provided by a hearing aid supplier.
The focus is to increase patient involvement in the rehabilitation process, utilize adjustment possibilities in everyday sound environments, and improve access to hearing care for the target population.
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: Self-monitoring of hearing aids using artificial intelligenceSelf-monitoring of hearing aids. ALl participants in this group are offered self-monitoring of hearing aids. |
| Standard care | Other | Other: Traditional hearing care at our clinics.All participants in this group are offered traditional hearing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who are eligible for a new or renewed hearing rehabilitation process at four of the Hearing organizations audiology clinics
Key exclusion criteria (1 listed)
- Not fullfilling the inclusion criteria
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 |
|---|---|---|
| Self-monitoring of hearing aids using artificial intelligenceSelf-monitoring of hearing aids using artificial intelligence | Device | Intervention group |
| Traditional hearing care at our clinics.Traditional hearing care at our clinics | Other | Standard care |
Primary outcome
Hearing Handicap Inventory for the Elderly-Screening
Time frame: From enrollment to the end of treatment at 6 months
Evaluates self-perceived psychosocial and emotional effects of hearing loss. Min 0 to max 100 points. Higher points equal greater self-perceived hearing problems.
2 secondary outcomes
Client Oriented Scale of Improvement
Time frame: From enrollment to the end of treatment at 6 months
Communication Strategies Scale of the Communication Profile for the Hearing Impaired
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
Milijana M Malmberg, PhD principal investigator
Habilitering & Hälsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring of hearing aids using artificial intelligence and Traditional hearing care at our clinics. in people with Hearing Loss, 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 1 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
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-Screening (time frame: From enrollment to the end of treatment at 6 months). 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 26 Oct 2026.