Actively Recruiting
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Randomized Controlled Trial With an Embedded Qualitative Study
Led by Zealand University Hospital · Updated on 2025-08-14
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
I
Interreg
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and user satisfaction of remote fine-tuning of hearing aids compared to traditional face-to-face adjustments in adults with hearing loss. This trial aims to find out if hearing aid outcomes, both self-reported and measured, are similar when using remote adjustment via a smartphone app versus in-person clinic visits. A qualitative study is also included to explore user experiences with remote fine-tuning. Participants are randomly assigned to either a remote fine-tuning group, where they use a smartphone app to adjust their hearing aids from home, or a face-to-face group, receiving adjustments in a clinic setting. The study includes five scheduled visits over three months, covering baseline measurements, hearing aid fittings, and follow-ups. The qualitative substudy separately collects interviews and observations to better understand users' views on remote fine-tuning. During the trial, participants complete questionnaires like SSQ-12, IOI-HA, and COSI, and undergo objective tests including Speech Intelligibility Index and speech comprehension in noise. Data collection spans from baseline before fitting to 12 weeks post-fitting. Researchers will monitor hearing aid effectiveness, hearing improvement, and user satisfaction. Safety and usability are tracked, and findings from both the randomized trial and the qualitative study will provide comprehensive insights.
CONDITIONS
Brief 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 want hearing aid treatment (18 years or older)
- Able to speak and read Danish
- Familiar with using a smartphone, including navigating apps and touchscreen
- Have access to a smartphone compatible with the hearing aid manufacturer's app
- Have a stable internet connection on their mobile device (Wi-Fi or mobile data)
You will not qualify if you...
- Patients with tinnitus requiring treatment or scoring over 58 on the Tinnitus Handicap Inventory
- Patients with Ménière disease due to dizziness, balance problems, and fluctuating hearing loss
- Patients who will receive in-the-ear hearing aids due to connectivity limitations
- Patients recommended or offered hearing aid treatment in only one ear
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks post-fitting
Participants receive fine-tuning of their hearing aids either remotely using a smartphone app or face-to-face in a clinic to adjust their hearing aids for optimal performance.
Initial fitting visit and follow-up visits during the 12 weeks
Duration - Up to 12 weeks post-fitting including assessments at 12 weeks
Participants complete assessments to evaluate hearing aid effectiveness, satisfaction, and hearing improvement after the treatment period.
1 visit at 12-week follow-up
Trial Site Locations
Total: 1 location
1
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
Research Team
N
Nagehan Altinkaya, phD student
B
Bjarki Ditlev Djurhuus
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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