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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03746548
Other study ID # 1573/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date June 30, 2019

Study information

Verified date December 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date June 30, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 99 Years
Eligibility 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

Study Design


Intervention

Device:
Adhear
Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
Contact Mini (CM)
Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks

Locations

Country Name City State
Austria MUW AKH Vienna

Sponsors (1)

Lead Sponsor Collaborator
Dominik Riss

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wearing time Wearing time per day of the two devices 1 year
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