Clinical trial NCT03746548: 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
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wearing time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: MUW AKH
Study officials:
References: