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

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.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss
• Intervention / Treatment: Device: Adhear; Device: Contact Mini (CM)

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
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • MUW AKH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CM-ADHEAR; First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device)	Device: Adhear; Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks; Device: Contact Mini (CM); Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
Other: ADHEAR - CM; First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband)	Device: Adhear; Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks; Device: Contact Mini (CM); Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wearing time	Wearing time per day of the two devices	1 year

Collaborators and Investigators

• Sponsor: Dominik Riss

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 18, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Conductive
• Other Study ID Numbers: 1573/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No