Status:
RECRUITING
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Interreg
Conditions:
Hearing Aid
Telehealth
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 recrui...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06992778
Start Date
May 27 2025
End Date
March 30 2026
Last Update
August 14 2025
Active Locations (1)
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1
Zealand University Hospital
Køge, Denmark, 4600