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NCT06992778
Effectiveness and Acceptability of Remote Fine-Tuning of Hearing Aids in Danish Adults
Conditions: Hearing Aid, Telehealth, Hearing Aid Fitting, Effectiveness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Zealand University Hospital
Location: Zealand University Hospital Køge
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.
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.
Source: ClinicalTrials.gov (NCT06992778). StuddyBuddy aggregates publicly available trial information.