Assessing the efficacy of a novel bone conduction tinnitus suppression device: a 30-day pilot study on clinical and audiological outcomes.

Purpose: This pilot study investigated the efficacy of a novel Tinnitus Retraining Therapy (TRT) device utilizing bone conduction white noise generation, in treating tinnitus in a normal hearing population.

Methods: This study was designed as a prospective, single-arm, observational trial in an outpatient clinic at a tertiary referral center, with 30 consecutive normal hearing patients with tinnitus. Tinnitus-specific questionnaires, namely the Tinnitus Handicap Inventory (THI) and Tinnitus Functional Index (TFI), translated and adapted to European Portuguese were administered. Patients were categorized into Group A (tinnitus characteristics within the device's maximum output performance) and Group B (outside the device's maximum output performance).

Results: 69% of the participants showed improvement in their TFI scores, with Group A exhibiting a significant mean reduction of 10 points (p = 0.0004). The device was well-tolerated, with no adverse effects reported.

Conclusion: The novel bone conduction tinnitus suppression device showed promise in reducing the impact of tinnitus, particularly in patients whose tinnitus profile is within the device maximum performance output. This improvement in TFI scores in the majority of the participants, observed after just a 30-day period, highlights the potential of specifically tailored sound therapy delivered via bone conduction in tinnitus management.