Conductive Hearing Loss
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEAdhear
Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
DEVICEContact Mini (CM)
Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
Sponsors
Dominik Riss
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria * Unilateral and/or bilateral conductive hearing loss (CHL) * The bone conduction threshold for the patient's affected ear shall be better than or equal to 25 dB HL (PTA BC for 0.5, 1, 2, 3 kHz). * Subjects aged 13 years or older * Capable of the German language * Willingness and ability to perform all tests required for the study * Signed, and dated informed consent before the start of any study specific procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearing time | 1 year | Wearing time per day of the two devices |
Countries
Austria
Outcome results
None listed