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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Conductive Hearing Loss

Intervention / Treatment
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* Device: Adhear
* Device: Contact Mini (CM)


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Exclusion criteria Pregnancy or breastfeeding Patient is intolerant of the materials as described by Manufacturer's IFU Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter. Patient cannot perform the audiological tests or is unable to fill out the questionnaires. Patient presents with retrocochlear, or central auditory disorder. any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CM-ADHEAR<br>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<br>* Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks<br>Device: Contact Mini (CM)<br>* Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks<br>|
| Other: ADHEAR - CM<br>First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband) | Device: Adhear<br>* Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks<br>Device: Contact Mini (CM)<br>* Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing time | Wearing time per day of the two devices | 1 year |