Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remote fine-tuning of hearing aids
DeviceRemote 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.
Face-to-face fine-tuning of hearing aids
DeviceIn the clinic, the standard procedure for fine-tuning hearing aids (HAs) involves a face-to-face consultation with an audiologist, typically lasting 30 minutes.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Intervention Group (IG)Experimental treatment 1 intervention
Group B: Control group (CG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments2
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".
Time frame
From baseline assessment (2-3 weeks before initial hearing aid fitting) to 12 weeks post-fitting, including all follow-up visits and assessments3
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
Time frame
At 12-week follow-up, assessing the participant's experience over the past 2 weeks.4
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).
Time frame
Measured at hearing aid fitting and 12 weeks post-fitting.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Interreg
Collaborator
Source ClinicalTrials.gov