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

NCT06992778 | Recruiting

• 1 other identifier: SJ-1072
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Aid; Telehealth; Hearing Aid Fitting; Effectiveness

Keywords

Remote fine-tuning; Teleaudiology; Randomized controlled trial (RCT); Hearing aids; Denmark

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

Remote Fine-Tuning of Hearing Aids Using Smartphone App

Device: Remote fine-tuning of hearing aids

Control group (CG)

ACTIVE COMPARATOR

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

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

Interventions

Remote fine-tuning of hearing aids 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.

Intervention Group (IG)

Face-to-face fine-tuning of hearing aids 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.

Control group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Interreg: collaborator

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Study Officials

• Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof

  Zealand University Hospital

  STUDY CHAIR

Central Study Contacts

Nagehan Altinkaya, phD student

CONTACT

+4560625058; nagal@regionsjaelland.dk

Bjarki Ditlev Djurhuus

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 28, 2025
• Study Start: May 27, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)