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

NCT03746548 | Completed

• 1 other identifier: 1573/2017
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Conductive Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Wearing time

  Wearing time per day of the two devices

  1 year

Study Arms (2)

CM-ADHEAR

OTHER

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

Device: Adhear; Device: Contact Mini (CM)

ADHEAR - CM

OTHER

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

Device: Adhear; Device: Contact Mini (CM)

Interventions

Adhear DEVICE

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

ADHEAR - CM; CM-ADHEAR

Contact Mini (CM) DEVICE

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

ADHEAR - CM; CM-ADHEAR

Eligibility Criteria

• Age: 13 Years - 99 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dominik Riss: 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. PD. Dr.

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 19, 2018
• Study Start: January 1, 2018
• Primary Completion: February 18, 2019
• Study Completion: June 30, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)