OBJECTIVES: The main aim of this study was to compare the average daily wearing time of a conventional bone conduction device with a pressure-free, adhesive bone conduction device. Further, audiologic and quality-of-life outcome parameters were evaluated. METHODS: An academic, prospective, randomized cross-over trial was performed at a single center.Thirteen subjects between 12 and 63 years with conductive hearing loss were included.Average daily wearing time and subjective observations were assessed in a diary. Sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test in quiet and in noise were carried out after 2 weeks of habituation to each device. AQoL-8D and SSQ-12 questionnaires were completed at baseline and after a 2-week test interval. RESULTS:Median wearing time of the devices was 8.1 hours (5.8-10.2 interquartile range) for the adhesive and 4.3 hours (2.7-7.1) for the conventional bone conduction device, the difference was statistically significant (p = 0.033). There were no statistically significant differences in sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test when comparing the two devices. AQoL-8D and SSQ-12 showed a significant improvement with the devices in comparison with baseline, with no significant difference between devices in the total scores. Ten subjects reported pain using the conventional device, two subjects reported skin irritations using the adhesive device. CONCLUSION: For patients with mixed or conductive hearing loss, the adhesive device is a valuable alternative with a significantly longer daily wearing time.
RCT Entities:
OBJECTIVES: The main aim of this study was to compare the average daily wearing time of a conventional bone conduction device with a pressure-free, adhesive bone conduction device. Further, audiologic and quality-of-life outcome parameters were evaluated. METHODS: An academic, prospective, randomized cross-over trial was performed at a single center.Thirteen subjects between 12 and 63 years with conductive hearing loss were included.Average daily wearing time and subjective observations were assessed in a diary. Sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test in quiet and in noise were carried out after 2 weeks of habituation to each device. AQoL-8D and SSQ-12 questionnaires were completed at baseline and after a 2-week test interval. RESULTS: Median wearing time of the devices was 8.1 hours (5.8-10.2 interquartile range) for the adhesive and 4.3 hours (2.7-7.1) for the conventional bone conduction device, the difference was statistically significant (p = 0.033). There were no statistically significant differences in sound field audiometry, Freiburg monosyllables word test, and Oldenburg sentence test when comparing the two devices. AQoL-8D and SSQ-12 showed a significant improvement with the devices in comparison with baseline, with no significant difference between devices in the total scores. Ten subjects reported pain using the conventional device, two subjects reported skin irritations using the adhesive device. CONCLUSION: For patients with mixed or conductive hearing loss, the adhesive device is a valuable alternative with a significantly longer daily wearing time.