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Clinical Performance of a New Implant System for Bone Conduction Hearing

NCT03086135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-10-14

Study results available
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Summary

To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.

Conditions

  • Deafness; Sensoneural Single Sided
  • Conductive Hearing Loss
  • Mixed Hearing Loss

Interventions

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.

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Emmanuel Mylanus, Prof. · Radboud Univerity Medical centre

  • Robert Briggs, Prof. · The Royal Victorian Eye and Ear Hospita

  • Susan Arndt, Prof. · Universitätsklinikum Freiburg

  • Piotr Skarżyński, Ass.Prof. · Center of Hearing and Speech

  • Henry Alexander Arts, Prof. · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2018-10-30
Completion
2019-06-20
FDA Device
Yes

Countries

  • United States
  • Australia
  • Germany
  • Netherlands
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03086135 on ClinicalTrials.gov