Evaluating remote fine-tuning of hearing aids for Danish adults
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
This study is testing if adjusting hearing aids through a smartphone app at home is just as effective and satisfying for Danish adults as getting adjustments in person at a clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge) |
| Trial ID | NCT06992778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness and user satisfaction of remote fine-tuning of hearing aids using a smartphone app compared to traditional face-to-face adjustments. Participants will be randomized into two groups: one receiving remote adjustments from home and the other attending in-person sessions at a clinic. The study will include five consultations over three months, with both self-reported and objective measures of hearing aid outcomes being collected. Additionally, a qualitative substudy will explore user experiences to provide insights into the acceptability and usability of the remote fine-tuning approach.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking adults over 18 with hearing loss who are comfortable using smartphones.
Not a fit: Patients with tinnitus requiring treatment, Ménière disease, or those needing in-the-ear hearing aids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accessibility and convenience of hearing aid adjustments for patients.
How similar studies have performed: Other studies have shown promise in teleaudiology approaches, suggesting potential success for this remote fine-tuning method.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Køge
- Zealand University Hospital — Køge, Denmark (Recruiting)
Study contacts
- Study coordinator: Nagehan Altinkaya, phD student
- Email: nagal@regionsjaelland.dk
- Phone: +4560625058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.