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NCT Number: NCT07711249

Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonova manufactured hearing aids with built-in Tinnitus feature

Device

Tinnitus-related annoyance before and after using Sonova manufactured hearing aids with built-in Tinnitus feature. Before use is considered the baseline.

Primary outcomes

  1. Tinnitus-related Annoyance

    Time frame: 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").

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Operations Manager

CONTACT

[email protected]

+41 58 928 01 01

Elliott Goff, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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