Tinnitus
Conditions
Brief summary
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
DEVICESonova 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.
Sponsors
Sonova AG
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus-related Annoyance | From enrollment to survey completion, roughly 15 minutes. | 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"). |
Contacts
CONTACTClinical Research Operations Manager
CONTACTElliott Goff, PhD
Outcome results
None listed