Application Detail

Status

Closed

Description of Medical Service

A direct-drive, implantable middle ear hearing prosthesis intended to provide a level of useful sound perception to individuals with hearing loss.
The system consists of two major components:

1. the implant, called Vibrating Ossicular Prosthesis, VORP; and
2. the external attachment, called the Audio Processor, AP.

The VORP is implanted during a surgical procedure. It consists of the Floating Mass Transducer (FMT), a conductor link, an electronic package and a magnet surrounded by an internal coil. The FMT is surgically attached to a vibratory structure of the ear. When activated, the FMT vibrates in a controlled manner causing the structure of the ear to vibrate. These vibrations are interpreted by the patient as sound. The signal to drive the FMT is transferred through the patient’s skin to the internal coil and then relayed to the FMT.
The Audio Processor is applied to the patient’s head after the patient has healed from surgery. It contains a microphone, processing electronics and a battery for power. The Audio Processor is held to the patient’s head by a magnet. The Audio Processor is adjusted by an audiologist, or other trained personnel, so that its output properly drives the FMT.
The system is intended to improve hearing acuity in adults who have moderate to severe hearing loss and who cannot wear a standard acoustic hearing aid for medical or physiological reasons.

Description of Medical Condition

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Reason for Application

-

Medical Service Type

-

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

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Assessment Report

Assessment Report (PDF 836 KB)
Assessment Report (Word 2456 KB)

Public Summary Document

Public Summary Document (PDF 50 KB)
Public Summary Document (Word 101 KB)

MSAC One Page Summary (PDF 16 KB)
MSAC One Page Summary (Word 25 KB)

Meetings for this Application

PASC

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ESC

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MSAC

29 - 30 July 2010