Quality of Life With Bone Conduction Hearing Device

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    36
  • sponsor
    Medical University of Vienna
Updated on 26 April 2022
deafness
bilateral conductive hearing loss

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.

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.

Details
Condition Conductive Hearing Loss
Treatment Bone conduction device (ADHEAR)
Clinical Study IdentifierNCT03864731
SponsorMedical University of Vienna
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note