NCT03327194

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

Subjective Satisfaction and Audiological Benefit With ADHEAR Audio Processor and ADHEAR Adhesive Adapter in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Queen Fabiola Children's University Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Conductive Hearing Loss
• Single Sided Deafness

Interventions

Type	Name	Description
DEVICE	ADHEAR Audio Processor	ADHEAR Audio Processoris a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle. The ADHEAR Audio Processor transmits sounds to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery. ADHEAR Audio Processor is classified as a Class lla medical device and ADHEAR Adhesive Adapter is classified as a Class I medical device. The ADHEAR Audio Processor has the CE mark.

Timeline

• Start date: 2018-01-31
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2017-10-31
• Last updated: 2018-02-15

Locations

1 site across 1 country: Belgium