Quality of Life With Bone Conduction Hearing Device

NCT03864731 | Completed

• 1 other identifier: 2087/2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Conductive Hearing Loss

Outcome Measures

Primary Outcomes (1)

• AQoL (Assessment of Quality of Life) Results

  The primary objective of this study is to evaluate, whether patients using ADHEAR have a significantly improved quality of life compared to patients not fitted with a device with the AQoL (Assessment of Quality of Life) questionnaire. It comprises 35 questions covering a multitude of quality of life aspects. Weighted utilities are generated using the algorithms provided on the AQoL website. Weighted utilities give a number between 0 and 1 as answer for every question. These sub scores are then presented.

  4 months

Study Arms (1)

Bone conduction device - ADHEAR

OTHER

Patients will receive a hearing aid (ADHEAR). Hearing assessment will be carried out. Quality of life measurement will be carried out.

Device: Bone conduction device (ADHEAR)

Interventions

Bone conduction device (ADHEAR) DEVICE

adhesive bone conduction device

Bone conduction device - ADHEAR

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

MUW AKH

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valerie Dahm, MD

  MUW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: March 6, 2019
• Study Start: February 25, 2019
• Primary Completion: July 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)