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

NCT ID: NCT06992778

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2026-03-30

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.

Detailed 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.

Conditions

Hearing Aid; Telehealth; Hearing Aid Fitting; Effectiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group (IG)

Remote Fine-Tuning of Hearing Aids Using Smartphone App

Group Type: EXPERIMENTAL

Remote fine-tuning of hearing aids

Intervention Type: 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.

Control group (CG)

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

Group Type: ACTIVE_COMPARATOR

Face-to-face fine-tuning of hearing aids

Intervention Type: 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.

Interventions

Remote fine-tuning of hearing aids

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.

Intervention Type: DEVICE

Face-to-face fine-tuning of hearing aids

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Interreg

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof

Role: STUDY_CHAIR

Zealand University Hospital

Locations

Zealand University Hospital

Køge, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nagehan Altinkaya, phD student

Role: CONTACT

nagal@regionsjaelland.dk

+4560625058

Bjarki Ditlev Djurhuus

Role: CONTACT

Facility Contacts

Nagehan Altinkaya, phD student

Role: primary

nagal@regionsjaelland.dk

+4560625058

Other Identifiers

SJ-1072

Identifier Type: -

Identifier Source: org_study_id