Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users

NCT ID: NCT03766152

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-13

Brief Summary

Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.

Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.

Detailed Description

Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.

No patients will be implanted with a Bonebridge as part of the study.

Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.

Questionnaires consist of the AQol-8D and the SSQ-12

Conditions

Bone Conduction Deafness; Hearing Loss, Conductive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adhear

Patients will be fitted with an adhesive bone conduction device for three weeks

Group Type: OTHER

Adhesive bone conduction hearing aid (ADHEAR - Med El)

Intervention Type: DEVICE

Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter

Interventions

Adhesive bone conduction hearing aid (ADHEAR - Med El)

Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients implanted with a Bonebridge device and are active users
• Unilateral and/or bilateral conductive hearing loss (CHL)
• 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

1757/2018

Identifier Type: -

Identifier Source: org_study_id