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

Exploring the Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults: A Non-blinded, Non-inferiority Randomized Controlled Trial With an Embedded Qualitative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Telehealth; Effectiveness; Hearing Aid; Hearing Aid Fitting
• Intervention / Treatment: Device: Remote fine-tuning of hearing aids; Device: Face-to-face fine-tuning of hearing aids

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nagehan Altinkaya, phD student; Phone Number: +4560625058; Email: nagal@regionsjaelland.dk
• Study Contact Backup: Name: Bjarki Ditlev Djurhuus

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Recruiting
    • Zealand University Hospital
    • Contact: Nagehan Altinkaya, phD student; Phone Number: +4560625058; Email: nagal@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (IG); Remote Fine-Tuning of Hearing Aids Using Smartphone App	Device: 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.
Active Comparator: Control group (CG); Face-to-Face Fine-Tuning of Hearing Aids in Clinic	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Self-Reported Hearing Aid Effectiveness	This outcome measures self-reported hearing aid effectiveness using the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12) Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting. Scoring: SSQ-12 items are rated on a scale of 0-10, with higher scores indicating better hearing perception.	From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
Change from Baseline in Self-Reported Improvement in Hearing	This outcome measures self-reported improvement in hearing using the Client Oriented Scale of Improvement (COSI). Measured at: Baseline (2-3 weeks before hearing aid fitting) and at 12 weeks post-fitting. Scoring: COSI evaluates improvement in personally relevant listening situations using a five-point scale from "worse" to "much better".	From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
Self-Reported Hearing Aid Satisfaction at 12-Week Follow-Up	This outcome assesses overall hearing aid satisfaction using the 'International Outcome Inventory for Hearing Aids' (IOI-HA). Measured at: 12-week follow-up consultation only. Scoring: The IOI-HA consists of 7 items, each designed to assess hearing aid benefit across different domains. Each item is scored on a 1 to 5 scale, where 1 represents the worst outcome and 5 represents the best outcome	At 12-week follow-up, assessing the participant's experience over the past 2 weeks.
Change from Baseline in Speech Intelligibility Index (SII)	This outcome evaluates changes in speech intelligibility using the Aided Speech Intelligibility Index (SII), measured during real-ear-measurement (REM) verification. Measured at: Baseline (hearing aid fitting) and at 12-week follow-up. Scoring: SII is calculated following ANSI standards (ANSI S3.5-1997), with values ranging from 0 (no speech audibility) to 1.0 (full speech audibility).	Measured at hearing aid fitting and 12 weeks post-fitting.
Change from Baseline in Discrimination Score in Free Field (DS-FF)	This outcome measures changes in speech discrimination ability using the Discrimination Score in Free Field (DS-FF) test under controlled conditions. Measured at: Baseline (at initial hearing aid fitting) and at 12-week follow-up. Scoring: Speech discrimination performance will be assessed in noise at a speech level of 65 dB SPL. The outcome is expressed as a percentage score (0-100%), where higher percentages indicate better speech discrimination ability. Testing is conducted using DANTALE-1, a validated Danish speech material.	Measured at initial hearing aid fitting and 12 weeks post-fitting.

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Interreg
• Investigators: Study Chair: Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: May 19, 2025
• First Posted (Actual): May 28, 2025

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial (RCT); Denmark; Hearing aids; Teleaudiology; Remote fine-tuning
• Other Study ID Numbers: SJ-1072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No