Efficacy of sound therapy in chronic tinnitus patients with mild hearing loss: a multicentre, double-blind, placebo-controlled randomized clinical trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Chronic tinnitus affects 10–15% of the population and can substantially impair quality of life. Sound therapies, including amplification and sound generators, are commonly used, but evidence from placebo-controlled trials remains limited. This multicenter, double-blind, placebo-controlled randomized trial evaluated the efficacy of sound therapy in adults with chronic bilateral tinnitus and mild hearing loss. Participants with tinnitus (THI ≥ 38) and mild bilateral hearing loss (PTA < 35 dB HL at 0.5–4 kHz) were randomized (1:1:1) to receive placebo amplification, sound generators, or sound generators combined with amplification. The intervention lasted 12 weeks and included a 6-week monotherapy phase followed by a 6-week polytherapy phase, during which participants in the active arms could switch between amplification, sound generators, or a combined approach. The primary outcome, change in Tinnitus Functional Index (TFI) score, improved significantly in the active treatment arms compared with placebo (mean change: -21 and − 18 vs. -6; p < .001). Clinically meaningful improvement on the Global Rating of Change Scale was reported by 88% of participants in the sound generator group, 77% in the combined therapy group, and 33% in the placebo group ( p < .001). These findings support sound therapy as an effective intervention for chronic tinnitus in individuals with mild hearing loss.
Source: Scientific Reports
Authors: Philippe Fournier, Hung Thai-Van, Pierre Reynard, Stéphane Gallego, Florine Liegeon, Alexandra Weckel, Paul Viudez, Vincent Loche, Ophélie Lépingle, Christine Holler-Houdoux, Valérie Villatte, Damien Bonnard, Matthieu Del Rio, Michel Kossowski, Alain Londero, Hervé Bischoff, Corinne Essebag, Arnaud Noreña, Marie-José Estève-Fraysse
Institutions: Centre National de la Recherche Scientifique, Inserm, Institut Pasteur, Université Paris Cité, Aix-Marseille Université, Université Laval, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale, Fondation Pour l'Audition, Institut de l'Audition, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Lyon 1 Université, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Hôpital Claude Huriez, REseau NAtional de Rpe interDisciplinaire, Nouvelles Cliniques Nantaises, Centre Hospitalier Universitaire de Bordeaux, Hôpital Paris Saint-Joseph, Assistance Publique – Hôpitaux de Paris, Hôpital Lariboisière
Language: English
Subfield: Sensory Systems
Field: Neuroscience
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $2,690
OpenAlex ID: W7220447014