search
Back to results

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

Primary Purpose

Conductive Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Adhear
Contact Mini (CM)
Sponsored by
Dominik Riss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conductive Hearing Loss

Eligibility Criteria

13 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MUW AKH

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CM-ADHEAR

ADHEAR - CM

Arm Description

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

First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband)

Outcomes

Primary Outcome Measures

Wearing time
Wearing time per day of the two devices

Secondary Outcome Measures

Full Information

First Posted
November 11, 2018
Last Updated
December 28, 2019
Sponsor
Dominik Riss
search

1. Study Identification

Unique Protocol Identification Number
NCT03746548
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominik Riss

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conductive Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CM-ADHEAR
Arm Type
Other
Arm Description
First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device)
Arm Title
ADHEAR - CM
Arm Type
Other
Arm Description
First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband)
Intervention Type
Device
Intervention Name(s)
Adhear
Intervention Description
Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
Intervention Type
Device
Intervention Name(s)
Contact Mini (CM)
Intervention Description
Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
Primary Outcome Measure Information:
Title
Wearing time
Description
Wearing time per day of the two devices
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MUW AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs