Use of ADHEAR, a Non-Implantable Bone Conduction Hearing System, in Children With Single Sided Deafness and/or Conductive Hearing Loss

Queen Fabiola Children's University Hospital

Status

Unknown

Conditions

Single Sided Deafness

Conductive Hearing Loss

Treatments

Device: ADHEAR Audio Processor

Study type

Interventional

Funder types

Other

Identifiers

NCT03327194

P2017/ORL/ADHEAR

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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