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A Belgian Trial Tests How Modern Hearing Aids Quiet Tinnitus Distress

For the estimated 15% of adults worldwide who experience tinnitus, a persistent ringing or buzzing in the ears, relief remains a primary goal. A new clinical trial in Belgium is now assessing a standard tool—the hearing aid—for its specific ability to reduce tinnitus-related annoyance in real-world settings. The study, identified as NCT07711249, will measure the effect of a built-in noise generator in newer models of Sonova hearing aids on 170 participants.

Building on Two Established Therapies

Hearing loss is a major risk factor for tinnitus. Clinical guidelines already recommend hearing aids as a therapeutic option, primarily for their amplification benefit. Separately, sound therapy has long been used to help manage the perception of tinnitus. Modern hearing aids often combine these approaches by integrating a noise generator, sometimes called a tinnitus masker or sound generator.

This feature produces a gentle, customizable background sound—like white noise or ocean waves—intended to make the tinnitus less noticeable. A prior randomized controlled trial demonstrated the clinical efficacy of an earlier generation of Sonova hearing aids with this integrated noise generator in reducing tinnitus-related distress. The Belgian study aims to extend that evidence.

The Trial Design: Observing Real-World Use

This is an observational study. Instead of assigning an intervention in a controlled lab, researchers will observe outcomes from patients already using the technology as part of their standard care. The study will enroll subjects both retrospectively and prospectively from participating clinics.

The core intervention is the use of Sonova-manufactured hearing aids with the “Tinnitus Feature” activated. To be eligible, participants must have used this activated feature for at least 12 weeks prior to assessment. The primary measure is change in self-reported tinnitus annoyance using a Numerical Rating Scale (NRS), which participants complete during routine clinical visits.

Who Can Participate?

The investigators have set clear inclusion and exclusion criteria to define their study population. Eligible participants must be at least 18 years old and have chronic tinnitus lasting six months or longer. They must be fitted with at least one Sonova hearing aid where the tinnitus noise generator has been active for a minimum of 12 weeks. Crucially, they must also report being “at least a little bothered” by their tinnitus, defined as a score of 3 or higher on the NRS.

The study explicitly excludes individuals reporting pulsatile tinnitus, a rhythmic sound that often coincides with the heartbeat, as its cause and management can differ from non-pulsatile tinnitus. A key focus of the trial is to include participants with severe to profound hearing loss, a group that has been underrepresented in previous research on this combined technology.

Current Status and Scientific Goals

The trial’s status is listed as NOT_YET_RECRUITING. It aims to enroll 170 participants once the recruitment phase begins through affiliated clinical sites in Belgium. The protocol has received approval from a local Ethics Committee.

The study addresses two specific evidence gaps. First, it evaluates newer generations of hearing aid technology and their integrated tinnitus features. Second, it aims to generate data on the clinical benefit for patients with severe to profound hearing loss, for whom amplification and sound therapy parameters differ significantly from those with mild to moderate loss.

Potential Impact on Patient Care

If the study findings are positive, they will reinforce the role of modern hearing aids as a dual-purpose tool for both hearing rehabilitation and tinnitus management in everyday life. For audiologists and ear, nose, and throat (ENT) specialists, the results could provide clearer guidance on expected outcomes when recommending and fitting these devices, particularly for patients with more significant hearing loss.

For patients, the research underscores a move toward personalized, device-based management that operates continuously in the background. Success would support the idea that a single device offering amplification and therapeutic sound can provide measurable relief from tinnitus annoyance over the long term.

This article is for informational purposes only. Consult a qualified professional for personalised advice.

Source:
Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in Belgium (ClinicalTrials.gov: NCT07711249)