Efficacy of sound therapy in chronic tinnitus patients with mild hearing loss: a multicentre, double-blind, placebo-controlled randomized clinical trial
Chronic tinnitus associated with mild hearing loss
Participants are randomly allocated in a double-blind manner to one of three treatment groups for a 12-week intervention period. Arm 1 (placebo control): Participants receive placebo amplification through hearing aids programmed to provide no therapeutic amplification or sound therapy effect. Devices are worn according to standard clinical recommendations during daily activities for 12 weeks. Arm 2 (sound generator): Participants receive acoustic stimulation therapy delivered through bilateral sound generators. Participants use the devices daily during waking hours for 12 weeks. Arm 3 (combination therapy): Participants receive acoustic stimulation therapy delivered through devices providing both hearing aid amplification and sound generator functions. Participants use the devices daily during waking hours for 12 weeks. During the first 6 weeks (monotherapy phase), participants use only the intervention assigned by randomization. During the subsequent 6 weeks (polytherapy phase), participants in the active treatment groups are allowed to select among amplification alone, sound generator alone, or combined amplification and sound generator therapy according to personal preference, listening needs, and daily circumstances. Participants in the placebo group continue to receive placebo treatment throughout the study. Allocation is performed using randomized assignment, and participants and study personnel involved in outcome assessment remain blinded to treatment allocation throughout the trial.
1. Adults seeking clinical care for tinnitus as the primary complaint 2. Continuous bilateral or centrally perceived tinnitus present for at least 3 months 3. Mild bilateral hearing loss meeting one of the predefined eligible audiometric profiles 4. Disabling tinnitus, defined as a score ≥38 on the French version of the Tinnitus Handicap Inventory (THI) 5. Ability and willingness to provide informed consent and comply with study procedures
1. Identifiable otolaryngological disorder explaining the tinnitus 2. Hearing loss not meeting the predefined eligible audiometric profiles 3. Use of hearing aids, sound generators, or combination devices within the previous 12 months 4. Any condition likely to interfere with study participation or outcome assessment