Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults

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.

NCT Number	NCT06992778
Lead Sponsor	Zealand University Hospital Collaborators: Interreg
Conditions	Hearing Aid, Telehealth, Hearing Aid Fitting, Effectiveness
Enrollment	120 participants
Start Date	2025-05-27
Primary Completion	2026-03-30 (estimated)
Study Completion	2026-03-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-14