Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Recruiting now · Not applicable
Conditions studied: Hearing Aid, Telehealth, Hearing Aid Fitting, Effectiveness
In brief
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.
Key facts
- Study ID
- NCT06992778
- Run by
- Zealand University Hospital
- People needed
- 120
- Starts
- 2025-05-27
- Expected to finish
- 2026-03-30
- Last updated by the study team
- 2025-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Zealand University Hospital — Køge, Denmark (enrolling)
Full record on ClinicalTrials.gov
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