Sound therapy may offer meaningful relief for people with chronic tinnitus, even when their hearing loss is relatively mild. In a new clinical trial, patients receiving active sound therapy experienced greater improvements than those receiving placebo treatment.
Published in Scientific Reports, the study compared active sound therapy with placebo treatment in adults with chronic, bothersome bilateral tinnitus. After 12 weeks, participants receiving active treatment reported substantially greater reductions in tinnitus-related difficulties than those in the placebo group.
The findings are particularly notable because participants had relatively mild hearing loss—a group for whom the role of amplification and other sound-based treatments in tinnitus management has not always been clear.
Testing Sound Therapy Against a Placebo
The researchers recruited 145 adults from six specialized tinnitus clinics across France. Participants had experienced continuous bilateral or centrally perceived tinnitus for at least three months and had mild hearing loss in both ears. To qualify, their tinnitus also had to cause at least a moderate level of difficulty based on a standardized tinnitus questionnaire.
Of those enrolled, 128 participants completed the study and were included in the final analysis. Their average age was 54.
Participants were randomly assigned to one of three groups:
- Placebo amplification
- Sound generator; or
- Combination of sound generation and hearing aid amplification.
All participants were fitted with hearing aids, but those in the placebo group received devices programmed to transmit sound without providing actual amplification.
The study was double-blinded: participants, ENT specialists, and researchers did not know which treatment participants had received. Only the audiologists responsible for programming the devices knew the treatment assignments.
During the first six weeks, participants followed their assigned treatment. For the second six weeks, those in the active treatment groups were given greater flexibility and could choose among amplification alone, a sound generator, or a combination of the two depending on their needs and listening environment.
All participants also received standardized counseling about tinnitus, its possible causes, and factors that can make symptoms better or worse.
Tinnitus Distress Declined with Active Sound Therapy
The primary measure was the Tinnitus Functional Index (TFI), a questionnaire designed to assess how tinnitus affects daily life. A reduction of at least 13 points is generally considered a clinically meaningful improvement.
After 12 weeks, average TFI scores fell by approximately 21 points in the sound-generator group and 18 points in the group initially receiving sound generation plus amplification. By comparison, the placebo group improved by about six points.
Participants’ own impressions of their progress showed a similar pattern. At the end of treatment, 88% of participants in the sound-generator group and 77% in the combined-treatment group reported at least some meaningful improvement, compared with 33% of those receiving placebo treatment.
Measures of tinnitus annoyance and perceived intensity also improved more in the active treatment groups. Importantly, the researchers observed some improvement in the placebo group as well, suggesting that counseling, clinical attention, expectations, and other nonspecific treatment effects may contribute to the overall experience of tinnitus care.
The active therapies, however, produced substantially greater improvements than placebo.
Mild Hearing Loss May Still Matter in Tinnitus Care
One of the more clinically relevant aspects of the study was how little hearing loss many participants had. The average hearing threshold across key speech frequencies was approximately 16 dB HL, meaning some patients might not traditionally be viewed as obvious candidates for hearing aids based on their hearing thresholds alone.
The results suggest that hearing status should not necessarily be considered in isolation when evaluating someone whose primary complaint is bothersome tinnitus.
The study also offered an interesting glimpse into how patients actually used the technology. Once participants in the active groups were allowed to select among different programs, amplification-only settings accounted for more than half of their use on average. The authors therefore caution that the final 12-week results are better viewed as evidence for a flexible, personalized sound-therapy strategy rather than proof that one particular sound therapy is superior.
Measures of sleep, anxiety, depression, and listening ability improved across all three groups, but there were no clear differences between the treatment groups on these broader outcomes.
What the Study Does—and Doesn’t—Show
The researchers describe the trial as one of the first multicenter, double-blind, placebo-controlled randomized studies to evaluate sound therapy delivered through hearing aids for tinnitus management.
Still, several limitations are important. The study did not include an amplification-only group during its initial randomized phase, making it difficult to determine exactly how much of the benefit came from amplification versus sound generation or their combination. The total treatment period was also only three months, so the study cannot show whether the improvements persist over the longer term.
Most importantly, the results apply specifically to people with chronic, bothersome tinnitus accompanied by mild bilateral hearing loss. They should not automatically be extended to people with normal hearing or more substantial hearing loss.
Even with those caveats, the findings provide stronger controlled evidence that sound-based treatment may have a meaningful role for patients whose tinnitus is troublesome even when their measured hearing loss would be considered relatively mild.
For clinicians, the results also reinforce the value of an individualized approach. Rather than relying on a single fixed program, patients may benefit from having access to amplification, sound generation, or a combination of the two depending on their listening environment and individual response.
Reference
Fournier P, Thai-Van H, Reynard P, et al. Efficacy of sound therapy in chronic tinnitus patients with mild hearing loss: a multicentre, double-blind, placebo-controlled randomized clinical trial. Scientific Reports. 2026. doi:10.1038/s41598-026-67678-5.
