Evaluating remote fine-tuning of hearing aids for Danish adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness and user satisfaction of remote fine-tuning of hearing aids using a smartphone app compared to traditional face-to-face adjustments. Participants will be randomized into two groups: one receiving remote adjustments from home and the other attending in-person sessions at a clinic. The study will include five consultations over three months, with both self-reported and objective measures of hearing aid outcomes being collected. Additionally, a qualitative substudy will explore user experiences to provide insights into the acceptability and usability of the remote fine-tuning approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zealand University Hospital
  Køge, Denmark Recruiting

Study contacts

• Study coordinator: Nagehan Altinkaya, phD student
• Email: nagal@regionsjaelland.dk
• Phone: +4560625058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.