Clinical Performance of a New Implant System for Bone Conduction Hearing

Cochlear

Status: Completed

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

Treatments: Device: Osia System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086135

CBAS5539

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Bone-conduction hearing device

Experimental group

Description:

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.

Treatment:

Device: Osia System