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
Qualifiers
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
Treatments tested in this trial
- Remote fine-tuning of hearing aids
- Face-to-face fine-tuning of hearing aids
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Zealand University Hospital
Lead sponsor
Interreg
Collaborator
Source ClinicalTrials.gov