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Completed

NCT Number: NCT03746548

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.

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Key information

Conditions

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

Age range

13 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUW AKH

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adhear

Device

Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks

Contact Mini (CM)

Device

Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks

Primary outcomes

  1. Wearing time

    Time frame: 1 year

    Wearing time per day of the two devices

Sponsors and collaborators

Lead sponsor

Dominik Riss

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2018
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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