POWERED INCUS REPLACEMENT PROSTHESIS

THE OBJECTIVE OF THIS RESEARCH IS TO BUILD AND TEST A POWERED INCUS REPLACEMENT PROSTHESIS (PIRP) FOR USE IN INDIVIDUALS WITH CONDUCTIVE AND SENSORINEURAL HEARING LOSSES. THIS DEVICE IS SURGICALLY IMPLANTED IN THE MIDDLE EAR REPLACING THE INCUS. THE PIRP CONSISTS OF THREE COMPONENTS. THEY INCLUDE; 1) A MALLEUS SENSOR, 2) A SIGNAL CONDITIONING AND POWER UNIT (SCPU), AND 3) A STAPES DRIVER. THE MALLEUS SENSOR IS ATTACHED TO THE HEAD OF THE MALLEUS BONE AND MEASURES THE STRUCTURAL DYNAMICS OF THE EARDRUM RESPONDING TO SOUND. OUTPUT FROM THE MALLEUS SENSOR IS AMPLIFIED BY THE SCPU AND VIBRATES THE STAPES DRIVER. A NON-RECHARGEABLE LITHIUM CELL SUPPLIES POWER TO ALL THREE COMPONENTS. THE PIRP WILL AMPLIFY SOUND PRESSURE AT THE EARDRUM. A MINIMUM 3 YEAR BATTERY LIFE IS EXPECTED. AN OUTPATIENT SURGICAL PROCEDURE CAN REPLACE THE LITHIUM CELL. SINCE THE PIRP IS AN INTEGRAL PART OF THE MIDDLE EAR, THE NATURAL DYNAMIC RANGE AND FREQUENCY RESPONSE OF A HEALTHY MIDDLE EAR MAY BE RESTORED. THIS DEVICE HAS GREAT COSMETIC APPEAL BECAUSE THERE IS NO EXTERNAL APPARATUS. A TEAM CONSISTING OF A TECHNICAL MANAGER, TRANSDUCER ENGINEER, TWO EAR SURGEONS AND A BIOMEDICAL ENGINEER, WILL COMBINE THEIR EXPERTISE TO 1) DETERMINE THE OPERATING PARAMETERS FOR THE PIRP, 2) FORMULATE A SUITABLE FINAL DESIGN FOR EACH COMPONENT, AND 3) FABRICATE AND TEST A PROTOTYPE UNIT. IN PHASE I RESEARCH, FRESH TEMPORAL BONES WERE USED TO HELP EVALUATE THE MALLEUS SENSOR, STAPES DRIVER AND SCPU. WE BELIEVE THE PIRP CAN BE A SIGNIFICANT ADVANCEMENT IN MIDDLE EAR REPLACEMENT DEVICES AND HEARING AID IMPLANTS. THE PIRP IS TOTALLY CONCEALED IN THE MIDDLE EAR AND REQUIRES NO DAILY MAINTENANCE. IT DOES NOT INTERFERE WITH NORMAL ACTIVITIES LIKE SHOWERING, SWIMMING OR SLEEPING. THE PIRP INDIRECTLY MEASURES THE SOUND PRESSURE IN THE EAR CANAL.