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| Name | Class |
|---|---|
| Interreg | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (IG) | Experimental | Remote Fine-Tuning of Hearing Aids Using Smartphone App |
|
| Control group (CG) | Active Comparator | Face-to-Face Fine-Tuning of Hearing Aids in Clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote fine-tuning of hearing aids | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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". | 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 | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nagehan Altinkaya, phD student | Contact | +4560625058 | nagal@regionsjaelland.dk | |
| Bjarki Ditlev Djurhuus | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof | Zealand University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zealand University Hospital | Recruiting | Køge | 4600 | Denmark |
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| Face-to-face fine-tuning of hearing aids | Device | 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. |
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| 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 at initial hearing aid fitting and 12 weeks post-fitting. |