Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini

Conductive Hearing Loss Clinical Trial

Official title: Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini

Status Completed

Clinical Trial Summary

Patients with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. They will wear either device for two weeks. They will use the second device for another two weeks. Audiologic tests and quality of life questionnaires will be assessed at the beginning of the study after two weeks with the first device and after two weeks with the second device. Additionally, all patients will be asked to keep a diary including daily wearing time of the device.

Clinical Trial Description

The primary objective of this study is to show, that the ADHEAR will be worn ~75%(~11 to 15 hours per day) of the waking hours, whereas the Contact Mini will be worn ~ 50% (~5 - 8 hours per day) of the waking hours (p<0.05). The authors expect this difference due to increased wearing comfort, reduced/no pressure to the skin of the ADHEAR. The primary objective will be assessed with the diary patients are asked to use.

Audiologic testing will consist of free field audiometry, Freiburger monosyllables test and Oldenburg sentence test. All tests will be performed with and without the devices.

Quality of life and hearing related questionnaires will consist of the AQoL-8D and the SSQ12. ;

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Hearing Loss
• Hearing Loss, Conductive

• NCT number: NCT03746548
• Study type: Interventional
• Source: Medical University of Vienna
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Completion date: June 30, 2019