Quality of Life With Bone Conduction Hearing Device

Brief Title

Quality of Life With Bone Conduction Hearing Device

Official Title

Audiological Benefit and Improved Quality of Life in Patients With a Bone Conduction Device - a Randomized Controlled Trial

Brief Summary

      The aim of this study is to compare the audiological and quality of life performance patients
      have with an ADHEAR (adhesive bone conduction device) compared to no hearing device.
    

Detailed Description

      Patients will be recruited at the outpatient's department of the Medical University of Vienna
      - Otorhinolaryngology department. Patient will be asked to participate in the study when
      inclusion and exclusion criteria are met. Mostly patients scheduled for a surgery improving
      conductive hearing loss or scheduled for implantation of an implantable bone conduction
      hearing aid will be included in the study.

      Patients who do not use a hearing aid and who are not planning on using a hearing aid meeting
      the inclusion and exclusion criteria will also be asked to participate in the study. After
      inclusion in the study patients will be asked to fill out two questionnaires (quality of life
      and hearing specific questionnaire). They will then be fitted with an ADHEAR device and
      undergo unaided and aided soundfield audiometry. Randomization will be carried out
      (Randomization ratio 1.4:1) and patients in the intervention group will keep the device for
      the following 4 months with one visit after the first probation time of one month. At the one
      month mark patients in the control group will be asked to fill out the two questionnaires.
      Patients in the control group will be asked to return to the department and fill out the
      three questionnaires (SSQ-12 (Speech Spatial and Hearing Questionnaire), AQoL(Assessment of
      Quality of Life) and In-house questionnaire). Further audiologic assessment will be carried
      out. At this appointment patients will be able to talk about their experiences in the
      probation period und easily terminate the study in case of insufficient improvement, pain,
      skin irritations or other issues. At the four month mark patients in both groups will be
      asked to return for audiologic assessment and for filling out the questionnaires.
    


Study Type

Interventional


Primary Outcome

AQoL (Assessment of Quality of Life) Results


Condition

Conductive Hearing Loss

Intervention

Bone conduction device (ADHEAR)

Study Arms / Comparison Groups

 Bone conduction device - ADHEAR
Description:  Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out.

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

36

Start Date

February 25, 2019

Completion Date

May 31, 2020

Primary Completion Date

January 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Unilateral and/or bilateral conductive hearing loss (CHL)

          -  Conductive hearing loss >10 decibel on average

          -  Subjective benefit from the device

          -  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:

          -  Pregnancy or breastfeeding

          -  Patient uses a hearing aid or plans to acquire a hearing aid

          -  Patient is intolerant of the materials as described by Manufacturer

          -  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 - N/A

Accepts Healthy Volunteers

No

Contacts

Dominik Riss, MD, +4314040033300, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT03864731

Organization ID

2087/2018


Responsible Party

Principal Investigator

Study Sponsor

Medical University of Vienna


Study Sponsor

Dominik Riss, MD, Principal Investigator, MUW


Verification Date

April 2019