Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium
ConditionTinnitus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSonova AG
About this trial
Tinnitus, the perception of sound without an external source, affects around 15% of the global adult population (Jarach et al., 2022). For many, tinnitus is a mild annoyance, but a significant subset experiences severe distress, leading to reduced quality of life and increased healthcare burden. Hearing loss is a major risk factor for tinnitus (Biswas et al., 2023), and clinical guidelines recommend hearing aids as a therapeutic option (Langguth et al., 2023). In addition to amplification through hearing aids, sound therapy has long been used to help manage tinnitus (Sereda \& Hoare, 2024).
A recent randomized controlled trial has demonstrated the clinical efficacy of Sonova hearing aids with integrated noise generator (further referred to as "Tinnitus-feature") in reducing tinnitus-related distress. However, the evidence is limited for newer generations of hearing aids and for individuals with severe to profound hearing loss. This study aims to address these gaps by evaluating the clinical benefit of the noise generator feature in newer generations of Sonova hearing aids for adults with tinnitus and hearing loss and in patients with severe to profound hearing loss during routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants ≥ 18 years old
Participants with chronic tinnitus (≥ 6 months)
Participants with the Tinnitus feature activated
Participants that have completed the NRS during routine clinical practice and are at least a little bothered by their tinnitus (NRS ≥ 3)
Disqualifiers
None
Trial population
Local study population residing in Belgium.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Sonova manufactured hearing aids with built-in Tinnitus feature
DeviceTinnitus-related annoyance before and after using Sonova manufactured hearing aids with built-in Tinnitus feature. Before use is considered the baseline.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Tinnitus-related Annoyance
An 11-point Numeric Rating Scale (NRS) with values ranging from 0 to 10 with a verbal anchor at 0 ("not at all") and 10 ("very annoying").
Time frame
From enrollment to survey completion, roughly 15 minutes.Locations
Source ClinicalTrials.gov
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