Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonova manufactured hearing aids with built-in Tinnitus feature.
- Who it may be relevant to
- Registry conditions: Tinnitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study is designed to enroll subjects both retrospectively and prospectively. Eligible subjects will be identified and enrolled through the participating clinical site according to the Clinical Investigation Protocol, which was approved by the local Ethics Committee.
Interventions
- Device Sonova manufactured hearing aids with built-in Tinnitus feature
Tinnitus-related annoyance before and after using Sonova manufactured hearing aids with built-in Tinnitus feature. Before use is considered the baseline.
Primary outcome measures
- Tinnitus-related Annoyance [Time frame: From enrollment to survey completion, roughly 15 minutes.]
Eligibility criteria
Inclusion criteria
- 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)
- Participants with at least one Sonova manufactured hearing aid with the tinnitus feature activated for at least 12 weeks
Exclusion criteria
\- Participants reporting pulsatile tinnitus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07711249 · B3222026001920