NCT03509974

Early Experience of a New Implant System for Bone Conduction Hearing in the Pediatric Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

Summary

To study the initial experience with implanting and fitting a new Bone Conduction system in pediatric patient population with conductive, mixed or single-sided deafness.

Detailed description

Experimental: Bone-conduction hearing device The bone-conduction hearing device Osia system allows a direct bone-conduction through an osseointegrated implant. A magnet allows the external Sound Processor to be placed in the correct position over the implanted system including an inner magnet. Device: Osia System An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea

Conditions

• Unilateral Mixed Conductive and Sensorineural Hearing Loss (Diagnosis)
• Sensorineural Hearing Loss, Unilateral With Normal Hearing on the Contralateral Side

Interventions

Type	Name	Description
DEVICE	Osseointegrated Steady State Implant	Bone anchored, bone conduction hearing system

Timeline

• Start date: 2018-04-18
• Primary completion: 2020-02-20
• Completion: 2020-03-19
• First posted: 2018-04-27
• Last updated: 2021-10-22
• Results posted: 2021-02-01

Locations

1 site across 1 country: Canada