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

Sponsor: Zealand University Hospital • ClinicalTrials.gov ID: NCT06992778

Registry updated: 2026-09-18

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Description

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.

Interventions

Remote fine-tuning of hearing aids (Device)
Remote Fine-Tuning of Hearing Aids allows patients to adjust their hearing aids remotely, without having to visit a clinic. Using a mobile app on the patient's device, real-time adjustments are made based on their feedback, with immediate changes during the session. Unlike traditional face-to-face adjustments, this approach lets patients stay in their own familiar surroundings. This helps create a more accurate listening environment, as the adjustments are made based on the sounds they experience in their everyday life.
Face-to-face fine-tuning of hearing aids (Device)
In the clinic, the standard procedure for fine-tuning hearing aids (HAs) involves a face-to-face consultation with an audiologist, typically lasting 30 minutes.

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.

Conditions

Hearing Aid Telehealth Hearing Aid Fitting Effectiveness

Locations

Zealand University Hospital — Køge, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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