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

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Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Wearing time


Condition

Conductive Hearing Loss

Intervention

Adhear

Study Arms / Comparison Groups

 CM-ADHEAR
Description:  First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

13

Start Date

January 1, 2018

Completion Date

June 30, 2019

Primary Completion Date

February 18, 2019

Eligibility Criteria

        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
      

Gender

All

Ages

13 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT03746548

Organization ID

1573/2017


Responsible Party

Sponsor-Investigator

Study Sponsor

Dominik Riss


Study Sponsor

, , 


Verification Date

December 2019