An interventional study of Adhear and Contact Mini (CM) in Conductive Hearing Loss, sponsored by Dominik Riss. Completed at 1 site in Austria. Open to participants aged 13 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by Dominik Riss · Not applicable, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 13 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Dominik Riss is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Inclusion criteria
Exclusion Criteria:
Exclusion criteria
First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device)
Device: Adhear · Device: Contact Mini (CM)
First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband)
Device: Adhear · Device: Contact Mini (CM)
Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
Wearing time
Wearing time per day of the two devices
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Dominik Riss