Comparison of the clinical and audiometric performance of two bone conduction devices in patients with conductive or mixed hearing loss: a multicentre trial

Abstract

Background: bone conduction devices are the best therapeutical option for patients with conductive or mixed hearing loss who have external or middle ear pathologies, that cannot use conventional hearing aid devices. These devices are divided in two main groups according to their mechanism of action: transcutaneous and percutaneous devices. While percutaneous devices may achieve better audiometric performance, they are associated with higher complication rates compared to transcutaneous systems. In patients with more severe hearing loss, percutaneous devices are selected, however for those with moderate hearing loss, the optimal management is remains unclear. Objectives: The main objective is to compare hearing-related quality of life between a percutaneous (Ponto) and a transcutaneous bone conduction device (Osia) in patients with CHL/MHL with bone conduction thresholds between 45-55 dB. Secondary objectives include comparing audiometric outcomes, postoperative complications, daily hours of use and general quality of life of the two devices. Study design: This study is designed as a multicentre, prospective, and randomized clinical trial. Methods: a total of 50 participants with CHL/MHL with bone conduction thresholds between 45-55 dB will be recruited with a non-probabilistic consecutive sampling method in 6 different hospitals in Catalonia and will be randomly assigned to the control group (that will be implanted with Ponto) or the intervention group (that will be implanted with Osia). Variables will be collected preoperatively and during follow up visits. Data will be analysed by a blinded biostatistician to compare outcomes

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