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

Official title

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

Overview

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.

Interventions

• 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 experien
• 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.

Primary outcome measures

• Change from Baseline in Self-Reported Hearing Aid Effectiveness [Time frame: 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 [Time frame: 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 [Time frame: At 12-week follow-up, assessing the participant's experience over the past 2 weeks.]
• Change from Baseline in Speech Intelligibility Index (SII) [Time frame: Measured at hearing aid fitting and 12 weeks post-fitting.]
• Change from Baseline in Discrimination Score in Free Field (DS-FF) [Time frame: Measured at initial hearing aid fitting and 12 weeks post-fitting.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Zealand University Hospital — Køge

Identifiers

NCT: NCT06992778 · SJ-1072

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗