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

NCT07711249 | Not Yet Recruiting FDA Device

• 1 other identifier: B3222026001920
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus

Outcome Measures

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").

  From enrollment to survey completion, roughly 15 minutes.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Local study population residing in Belgium.

You may qualify if:

• 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

You may not qualify if:

• \- Participants reporting pulsatile tinnitus

Sponsors & Collaborators

• Sonova AG: lead

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Research Operations Manager

CONTACT

+41 58 928 01 01; ClinOpsCH@sonova.com

Elliott Goff, PhD

CONTACT

Elliott.Goff@sonova.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share