NCT06992778 Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
| NCT ID | NCT06992778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Hearing Aid |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-05-27 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof
STUDY CHAIR
Zealand University Hospital
Frequently Asked Questions
Who can join the NCT06992778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Aid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992778 currently recruiting?
Yes, NCT06992778 is actively recruiting participants. Contact the research team at nagal@regionsjaelland.dk for enrollment information.
Where is the NCT06992778 trial being conducted?
This trial is being conducted at Køge, Denmark.
Who is sponsoring the NCT06992778 clinical trial?
NCT06992778 is sponsored by Zealand University Hospital. The principal investigator is Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof at Zealand University Hospital. The trial plans to enroll 120 participants.