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

Last updated: August 13, 2025
Sponsor: Zealand University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Aid

Treatment

Face-to-face fine-tuning of hearing aids

Remote fine-tuning of hearing aids

Clinical Study ID

NCT06992778
SJ-1072
  • Ages > 18
  • All Genders

Study 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

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 asmartphone, including navigating menus, opening and closing apps, and interactingwith 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 ormobile data.

Exclusion

Exclusion Criteria:

  • Patients with tinnitus requiring treatment or scoring more than 58 in the 'TinnitusHandicap 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 potentiallimitations in connectivity for remote fine-tuning.

  • Patients which are recommended/offered unilateral HA treatment.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Face-to-face fine-tuning of hearing aids
Phase:
Study Start date:
May 27, 2025
Estimated Completion Date:
March 30, 2026

Study Description

In addition to the randomized controlled trial, a separate qualitative substudy is being conducted to explore user experiences related to the intervention. This component involves independently recruited participants who are not enrolled in the RCT. The qualitative substudy is designed to provide contextual insights into the acceptability, usability, and perceived value of remote fine-tuning of hearing aids from the user perspective. Data are collected through semi-structured interviews and/or observations, and findings will be reported separately to complement the RCT outcomes.

Connect with a study center

  • Zealand University Hospital

    Køge, 4600
    Denmark

    Active - Recruiting

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