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

Zealand University Hospital

Status: Enrolling

Conditions: Effectiveness; Hearing Aid; Hearing Aid Fitting; Telehealth

Treatments: Device: Face-to-face fine-tuning of hearing aids; Device: Remote fine-tuning of hearing aids

Study type: Interventional

Funder types: Other

Identifiers

NCT06992778

SJ-1072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention Group (IG)

Experimental group

Description:

Remote Fine-Tuning of Hearing Aids Using Smartphone App

Treatment:

Device: Remote fine-tuning of hearing aids

Control group (CG)

Active Comparator group

Description:

Face-to-Face Fine-Tuning of Hearing Aids in Clinic

Treatment:

Device: Face-to-face fine-tuning of hearing aids