Efficacy of hearing aid treatment on sound perception and residual hearing preservation in patients with tinnitus and coexisting hearing loss: study protocol for a randomized controlled trial

This study aims to identify and evaluate the efficacy of the use of HAs in both sound perception and residual hearing preservation among patients with tinnitus and coexisting SNHL.Methods and designThe present study is a prospective, single-center, outcome assessor and data analyst-blinded, randomized, controlled trial. Eligible participants will be recruited and randomly allocated into the HA intervention group and the waiting list control group at a ratio of 1:1. The primary outcome is to evaluate the severity of tinnitus using the Tinnitus Handicap Inventory as a continuous variable at 6 months from randomization. Secondary outcome measures include changes in hearing status and mental states. The trial will last 6 months, with follow-up visits at 3 months and 6 months.DiscussionThis will be the first randomized, controlled trial to identify and evaluate HAs ’ efficacy on residual hearing preservation among tinnitus patients with coexisting high-frequency SNHL in China. We are aiming for novelty and generalizability, and strengths of this study are that it will examine the effectiveness of HA in patients with tinnitus and hearing impairment and will f urther explore the residual hearing protection provided by HA treatment in the tinnitus group.Trial registrationClinicalTrials.gov NCT05343026. Registered on April 25, 2022
Source: Trials - Category: Research Source Type: clinical trials