Clinical Performance of a New Implant System for Bone Conduction Hearing

Completed · Not applicable

Conditions studied: Deafness; Sensoneural Single Sided, Conductive Hearing Loss, Mixed Hearing Loss

In brief

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

Key facts

Study ID

NCT03086135

Run by

Cochlear

People needed

51

Starts

2017-03-09

Expected to finish

2019-06-20

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult subjects (18 years or older)
• Subject with conductive or mixed hearing loss in the ear to be implanted. Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz) of 55 dB HL.
• OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 of 20 dB HL (mean of 0.5, 1, 2 and 3 kHz) in the good ear OR subject who is indicated for an AC CROS but-for some reason-cannot or will not use an AC CROS (Air Conduction-Contralateral Routing of Signal).
• Signed informed consent
• Previous experience from amplified sound though a non-surgical solution. (For example but not limited to Hearing aid, CROS device, Bone conductional hearing device on headband/ softband)

You may not qualify if…

• Uncontrolled diabetes as judged by the investigator.
• Condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator.
• Insufficient bone quality and quantity for implantation of a BI300 Implant.
• Subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period
• Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator
• Unable to follow investigational procedures, e.g. to complete quality of life scales.
• Participation in another clinical investigation with pharmaceutical and/or device.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• The Royal Victorian Eye and Ear Hospital — East Melbourne, Victoria, Australia
• University Medical Center Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Radboud University Medical Center — Nijmegen, Netherlands
• World Hearing Center Institute of Physiology and Pathology of Hearing — Kajetany, Nadarzyn, Poland

Full record on ClinicalTrials.gov

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