Actively Recruiting
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Led by Zealand University Hospital · Updated on 2025-08-14
120
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
I
Interreg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with hearing loss who desire hearing aid treatment (18 years or older)
- Ability to understand and speak Danish both orally and in writing
- Familiarity with operating a smartphone, including using menus and apps with audio and video call capability
- Access to a smartphone compatible with hearing aid manufacturers' system requirements
- Access to a stable network connection on the mobile device via Wi-Fi or mobile data
You will not qualify if you...
- Patients with tinnitus requiring treatment or scoring more than 58 on the Tinnitus Handicap Inventory
- Patients with M�E9ni�E8re disease due to dizziness, balance problems, and fluctuating hearing loss
- Patients who will receive in-the-ear (ITE) hearing aids due to connectivity limitations for remote fine-tuning
- Patients recommended or offered unilateral hearing aid treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
Research Team
N
Nagehan Altinkaya, phD student
CONTACT
B
Bjarki Ditlev Djurhuus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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