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Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

NCT04041700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2021-08-18

Study results available
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Summary

The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.

Conditions

Interventions

DEVICE

Osia 2 system

System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.

Sponsors & Collaborators

  • Statistiska Konsultgruppen

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Karin Ganlöv · Cochlear

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-16
Primary Completion
2020-06-19
Completion
2020-09-24

Countries

  • Australia
  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

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 NCT04041700 on ClinicalTrials.gov