Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Conductive Hearing Loss
- Sponsor
- Queen Fabiola Children's University Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Maximal decibels gain measured by Audiological basic tests
- Last Updated
- 8 years ago
Overview
Brief Summary
A hearing loss affects the quality of life and the natural development of children.
The new generation of hearing devices provides a huge number of options to them. These new hearing aids are often aesthetically acceptable, less invasive and user-friendly.
The ADHEAR Non-Implantable Bone Conduction Hearing System is connected directly to the skin with a special adhesive adapter. The device transmits the sound to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.
The objective of this study is to evaluate of the audiological benefit and subjective satisfaction of ADHEAR Audio Processor with Adhesive attachment in a group of children suffering from conductive hearing loss and/or single sided deafness.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Unilateral and/or bilateral CHL (e. g. BC-thresholds \<25dB HL)
- •Ability to perform all tests required for the study
- •Signed, and dated informed consent by parents and children where applicable
Exclusion Criteria
- •intolerant of the materials
- •patient with a skin or scalp condition that may preclude the attachment of the adhesive plaster
- •fluctuation of hearing loss over a two year period of 15dB in either direction
- •retrocochlear, or central auditory disorders
- •any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Outcomes
Primary Outcomes
Maximal decibels gain measured by Audiological basic tests
Time Frame: Week 3
Maximal decibels gain measured by speech reception threshold in quiet
Time Frame: Week 3
Secondary Outcomes
- Change from baseline in Quality of Life measured by the SSQ12 questionnaire(month 12)
- Comparison of maximal decibels gain measured by Audiological basic tests between ADHEAR Audio Processor and Cochlear bone anchored hearing aid.(Day 0)
- Comparison of maximal decibels gain measured by speech reception threshold in quiet between ADHEAR Audio Processor and Cochlear bone anchored hearing aid(Day 0)
- Change from baseline in patient and parents satisfaction measured by the ADHEAR Questionnaire(month 12)
- Incidence of device-emergent adverse event.(Up to 1 year after start of study device utilization)
- Number of subjects who discontinue study device utilization due to any AE or dissatisfaction(Year 1)
- Average time of daily use of ADHEAR System(week 3)