Clinical trial NCT06992778: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Aid
Telehealth
Hearing Aid Fitting
Effectiveness
Keywords: Remote fine-tuning
Teleaudiology
Randomized controlled trial (RCT)
Hearing aids
Denmark
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Interreg
First posted: 2025-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Self-Reported Hearing Aid Effectiveness
timeFrame: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
measure: Change from Baseline in Self-Reported Improvement in Hearing
timeFrame: From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments
measure: Self-Reported Hearing Aid Satisfaction at 12-Week Follow-Up
timeFrame: At 12-week follow-up, assessing the participant's experience over the past 2 weeks.
measure: Change from Baseline in Speech Intelligibility Index (SII)
timeFrame: Measured at hearing aid fitting and 12 weeks post-fitting.
measure: Change from Baseline in Discrimination Score in Free Field (DS-FF)
timeFrame: Measured at initial hearing aid fitting and 12 weeks post-fitting.
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Bjarki Ditlev Djurhuus, MD, PhD, Assoc Prof
role: STUDY_CHAIR
References: