Hearing AidEARFitNCT06992778
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
A study testing Remote fine-tuning of hearing aids and Face-to-face fine-tuning of hearing aids in people with Hearing Aid and Telehealth, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer: Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Aid, Telehealth, Hearing Aid Fitting
- What is being tested?
- Remote fine-tuning of hearing aids and Face-to-face fine-tuning of hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 27 May 2025to 31 Mar 2027
- 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
- Adult patients with hearing loss who desire HA treatment (+18 of age).
- Danish language skills both written and oral.
- Acquisition of digital proficiency in terms of being familiar with operating a smartphone, including navigating menus, opening and closing apps, and interacting with the touchscreen with capabilities for audio and video calls.
- Access to a smartphone that are compatible with manufacturers' system requirements.
- Access to a stable network connection on the mobile device, with either Wi-Fi or mobile data.
Who cannot join
- Patients with tinnitus requiring treatment or scoring more than 58 in the 'Tinnitus Handicap Inventory' (THI) grading system.
- Patients with Ménière disease, due to its complications and symptoms as dizziness, balance problems and fluctuating hearing loss, that can affect the HA treatment.
- Patients who will receive in-the-ear (ITE) hearing aids, due to potential limitations in connectivity for remote fine-tuning.
- Patients which are recommended/offered unilateral HA treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bjarki Ditlev Djurhuus contact
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Køge, 4600
Nagehan Altinkaya, phD student, +4560625058, nagal@regionsjaelland.dk
About this study
Official title: Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study
The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer:
- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments?
Read more
Researchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting.
Participants will:
- Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group).
- Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits.
Participants in the remote fine-tuning group will:
- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home.
Participants in the face-to-face group will:
- Visit the clinic for in-person fine-tuning appointments.
Data will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.
Read the detailed description
In addition to the randomized controlled trial, a separate qualitative substudy is being conducted to explore user experiences related to the intervention. This component involves independently recruited participants who are not enrolled in the RCT. The qualitative substudy is designed to provide contextual insights into the acceptability, usability, and perceived value of remote fine-tuning of hearing aids from the user perspective. Data are collected through semi-structured interviews and/or observations, and findings will be reported separately to complement the RCT outcomes.
- Conditions
- Hearing Aid, Telehealth, Hearing Aid Fitting, Effectiveness
- Being tested
- Remote fine-tuning of hearing aids, Face-to-face fine-tuning of hearing aids
- Keywords
- Remote fine-tuning, Teleaudiology, Randomized controlled trial (RCT), Hearing aids, Denmark
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote fine-tuning of hearing aidsDevice
Remote Fine-Tuning of Hearing Aids allows patients to adjust their hearing aids remotely, without having to visit a clinic. Using a mobile app on the patient's device, real-time adjustments are made based on their feedback, with immediate changes during the session.
Unlike traditional face-to-face adjustments, this approach lets patients stay in their own familiar surroundings. This helps create a more accurate listening environment, as the adjustments are made based on the sounds they experience in their everyday life.
Face-to-face fine-tuning of hearing aidsDevice
In the clinic, the standard procedure for fine-tuning hearing aids (HAs) involves a face-to-face consultation with an audiologist, typically lasting 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (IG) | Experimental | Remote Fine-Tuning of Hearing Aids Using Smartphone App Receives: Device: Remote fine-tuning of hearing aids |
| Control group (CG) | Active comparator | Face-to-Face Fine-Tuning of Hearing Aids in Clinic Receives: Device: Face-to-face fine-tuning of hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Reported Hearing Aid Effectiveness
This outcome measures self-reported hearing aid effectiveness using the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting.
Scoring: SSQ-12 items are rated on a scale of 0-10, with higher scores indicating better hearing perception.
Measured: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
Change from Baseline in Self-Reported Improvement in Hearing
This outcome measures self-reported improvement in hearing using the Client Oriented Scale of Improvement (COSI).
Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting.
Scoring: COSI evaluates improvement in personally relevant listening situations using a five-point scale from "worse" to "much better".
Measured: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
Self-Reported Hearing Aid Satisfaction at 12-Week Follow-Up
This outcome assesses overall hearing aid satisfaction using the 'International Outcome Inventory for Hearing Aids' (IOI-HA).
Measured at: 12-week follow-up consultation only.
Scoring: The IOI-HA consists of 7 items, each designed to assess hearing aid benefit across different domains. Each item is scored on a 1 to 5 scale, where 1 represents the worst outcome and 5 represents the best outcome
Measured: At 12-week follow-up, assessing the participant's experience over the past 2 weeks.
Change from Baseline in Speech Intelligibility Index (SII)
This outcome evaluates changes in speech intelligibility using the Aided Speech Intelligibility Index (SII), measured during real-ear-measurement (REM) verification.
Measured at: Baseline (hearing aid fitting) and at 12-week follow-up.
Scoring: SII is calculated following ANSI standards (ANSI S3.5-1997), with values ranging from 0 (no speech audibility) to 1.0 (full speech audibility).
Measured: Measured at hearing aid fitting and 12 weeks post-fitting.
Change from Baseline in Discrimination Score in Free Field (DS-FF)
This outcome measures changes in speech discrimination ability using the Discrimination Score in Free Field (DS-FF) test under controlled conditions.
Measured at: Baseline (at initial hearing aid fitting) and at 12-week follow-up.
Scoring: Speech discrimination performance will be assessed in noise at a speech level of 65 dB SPL. The outcome is expressed as a percentage score (0-100%), where higher percentages indicate better speech discrimination ability. Testing is conducted using DANTALE-1, a validated Danish speech material.
Measured: Measured at initial hearing aid fitting and 12 weeks post-fitting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start27 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing AidStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Interreg
- Responsible party
- Sponsor
- Investigators
- Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof, Study chair, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992778
- Sponsor's protocol ID
- SJ-1072
- Acronym
- EARFit
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study
- ClinicalTrials.gov ID
- NCT06992778
- Acronym / sponsor ID
- EARFit / SJ-1072
- Conditions
- Hearing Aid, Telehealth, Hearing Aid Fitting, Effectiveness
- Keywords
- Remote fine-tuning, Teleaudiology, Randomized controlled trial (RCT), Hearing aids, Denmark
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Interreg
- Study start
- 27 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 May 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.
The aim of this clinical trial is to evaluate the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments. The main questions aims to answer:
- Are hearing aid outcomes (self-reported and objective) similar when using remote fine-tuning compared to face-to-face adjustments?
Researchers will compare remote fine-tuning (using a smartphone app) to traditional face-to-face fine-tuning sessions in a clinical setting.
Participants will:
- Be randomized to either the remote fine-tuning group (intervention group) or the face-to-face adjustment group (control group).
- Attend five scheduled consultations over a 3-month period, including baseline measurements, hearing aid fittings, and follow-up visits.
Participants in the remote fine-tuning group will:
- Set up and use a hearing aid manufacturer's smartphone app to complete fine-tuning sessions from home.
Participants in the face-to-face group will:
- Visit the clinic for in-person fine-tuning appointments.
Data will be collected through questionnaires (e.g., SSQ-12, IOI-HA, and COSI) and objective measures such as the Speech Intelligibility Index (SII) and speech comprehension in noise (DS-FF). Additional qualitative data will be gathered from interviews with participants in the remote fine-tuning group.
Detailed description
In addition to the randomized controlled trial, a separate qualitative substudy is being conducted to explore user experiences related to the intervention. This component involves independently recruited participants who are not enrolled in the RCT. The qualitative substudy is designed to provide contextual insights into the acceptability, usability, and perceived value of remote fine-tuning of hearing aids from the user perspective. Data are collected through semi-structured interviews and/or observations, and findings will be reported separately to complement the RCT outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Device: Remote fine-tuning of hearing aidsRemote Fine-Tuning of Hearing Aids Using Smartphone App |
| Control group (CG) | Active comparator | Device: Face-to-face fine-tuning of hearing aidsFace-to-Face Fine-Tuning of Hearing Aids in Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with hearing loss who desire HA treatment (+18 of age).
- Danish language skills both written and oral.
- Acquisition of digital proficiency in terms of being familiar with operating a smartphone, including navigating menus, opening and closing apps, and interacting with the touchscreen with capabilities for audio and video calls.
- Access to a smartphone that are compatible with manufacturers' system requirements.
- Access to a stable network connection on the mobile device, with either Wi-Fi or mobile data.
Key exclusion criteria (4 listed)
- Patients with tinnitus requiring treatment or scoring more than 58 in the 'Tinnitus Handicap Inventory' (THI) grading system.
- Patients with Ménière disease, due to its complications and symptoms as dizziness, balance problems and fluctuating hearing loss, that can affect the HA treatment.
- Patients who will receive in-the-ear (ITE) hearing aids, due to potential limitations in connectivity for remote fine-tuning.
- Patients which are recommended/offered unilateral HA treatment.
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 fine-tuning of hearing aidsRemote Fine-Tuning of Hearing Aids allows patients to adjust their hearing aids remotely, without having to visit a clinic. Using a mobile app on the patient's device, real-time adjustments are made based on their feedback, with immediate changes during the session. Unlike traditional face-to-face adjustments, this approach lets patients stay in their own familiar surroundings. This helps create a more accurate listening environment, as the adjustments are made based on the sounds they experience in their everyday life. | Device | Intervention Group (IG) |
| Face-to-face fine-tuning of hearing aidsIn the clinic, the standard procedure for fine-tuning hearing aids (HAs) involves a face-to-face consultation with an audiologist, typically lasting 30 minutes. | Device | Control group (CG) |
Primary outcome
Change from Baseline in Self-Reported Hearing Aid Effectiveness
Time frame: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
This outcome measures self-reported hearing aid effectiveness using the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12) Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting. Scoring: SSQ-12 items are rated on a scale of 0-10, with higher scores indicating better hearing perception.
Change from Baseline in Self-Reported Improvement in Hearing
Time frame: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
This outcome measures self-reported improvement in hearing using the Client Oriented Scale of Improvement (COSI). Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting. Scoring: COSI evaluates improvement in personally relevant listening situations using a five-point scale from "worse" to "much better".
Self-Reported Hearing Aid Satisfaction at 12-Week Follow-Up
Time frame: At 12-week follow-up, assessing the participant's experience over the past 2 weeks.
This outcome assesses overall hearing aid satisfaction using the 'International Outcome Inventory for Hearing Aids' (IOI-HA). Measured at: 12-week follow-up consultation only. Scoring: The IOI-HA consists of 7 items, each designed to assess hearing aid benefit across different domains. Each item is scored on a 1 to 5 scale, where 1 represents the worst outcome and 5 represents the best outcome
Change from Baseline in Speech Intelligibility Index (SII)
Time frame: Measured at hearing aid fitting and 12 weeks post-fitting.
This outcome evaluates changes in speech intelligibility using the Aided Speech Intelligibility Index (SII), measured during real-ear-measurement (REM) verification. Measured at: Baseline (hearing aid fitting) and at 12-week follow-up. Scoring: SII is calculated following ANSI standards (ANSI S3.5-1997), with values ranging from 0 (no speech audibility) to 1.0 (full speech audibility).
Change from Baseline in Discrimination Score in Free Field (DS-FF)
Time frame: Measured at initial hearing aid fitting and 12 weeks post-fitting.
This outcome measures changes in speech discrimination ability using the Discrimination Score in Free Field (DS-FF) test under controlled conditions. Measured at: Baseline (at initial hearing aid fitting) and at 12-week follow-up. Scoring: Speech discrimination performance will be assessed in noise at a speech level of 65 dB SPL. The outcome is expressed as a percentage score (0-100%), where higher percentages indicate better speech discrimination ability. Testing is conducted using DANTALE-1, a validated Danish speech material.
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 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hearing Aid
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Performance of a Remote Microphone Compared to Hearing Aids Alone
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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.
Bjarki Ditlev Djurhuus contact
Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof study chair
Zealand University Hospital
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 fine-tuning of hearing aids and Face-to-face fine-tuning of hearing aids in people with Hearing Aid and Telehealth, run by Zealand University Hospital at 1 site in Denmark.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Sep 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 Denmark. 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?
Contact Nagehan Altinkaya, phD student (+4560625058, nagal@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Self-Reported Hearing Aid Effectiveness (time frame: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments). The study lists 5 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 18 Sep 2026.