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

Conductive Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746548
• Other study ID #: 1573/2017
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Hearing Loss
• Hearing Loss, Conductive

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