Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Active Osseointegrated Steady-State Implant System (OSI)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04754477

CBAS5793

Details and patient eligibility

About

The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751
• Willing and able to provide written informed consent

Exclusion criteria

• Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator
• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Active Osseointegrated Steady-State Implant System (OSI)

Experimental group

Treatment:

Device: Active Osseointegrated Steady-State Implant System (OSI)