Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Zealand University Hospital
RECRUITING
Køge
Contact Information
Primary
Nagehan Altinkaya, phD student
nagal@regionsjaelland.dk
+4560625058
Backup
Bjarki Ditlev Djurhuus
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 120
Treatments
Experimental: Intervention Group (IG)
Remote Fine-Tuning of Hearing Aids Using Smartphone App
Active_comparator: Control group (CG)
Face-to-Face Fine-Tuning of Hearing Aids in Clinic
Related Therapeutic Areas
Sponsors
Collaborators: Interreg
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov