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

NCT ID: NCT03746548

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-06-30

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.

Conditions

Conductive Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: OTHER

Adhear

Intervention Type: DEVICE

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

Contact Mini (CM)

Intervention Type: DEVICE

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

ADHEAR - CM

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

Group Type: OTHER

Adhear

Intervention Type: DEVICE

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

Contact Mini (CM)

Intervention Type: DEVICE

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

Interventions

Adhear

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

Intervention Type: DEVICE

Contact Mini (CM)

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

Intervention Type: DEVICE

Eligibility 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

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dominik Riss

OTHER

Sponsor Role: lead

Responsible Party

Dominik Riss

Assoc. Prof. PD. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

MUW AKH

Vienna, , Austria

Countries

Austria

Other Identifiers

1573/2017

Identifier Type: -

Identifier Source: org_study_id