PHONAK LYRIC4 (L)

Additional Manufacturer Narrative

MANUFACTURER INVESTIGATED THE INCIDENT. (4109): NO MARKET TREND HAS EVER BEEN OBSERVED FOR THIS ISSUE LOCALLY NOR GLOBALLY. (4112): THE FOLLOW UP INTERVIEW WITH THE HCP DETERMINED THAT THE PATIENT WAS NEW TO LYRIC AND THE HCP BELIEVES THE PATIENT WON'T CONTINUE WITH THIS DEVICE AS HE IS CURRENTLY IN TRIAL WITH RECEIVER IN CANAL DEVICE. THE PATIENT WAS USING LYRIC DEVICE IN BOTH EARS. DURATION OF WEAR WAS 8 DAYS. CONCERNING THE INCIDENT, THE PATIENT SELF-REMOVED THE DEVICE ON (B)(6). PROVIDER DID NOT SEE IT HIM UNTIL ON (B)(6). THE PATIENT REPORTED TO THE PROVIDER THAT THE DEVICE SHOWED "GREEN, GOOPY PUTRID SMELLING DISCHARGE" WHEN REMOVED. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AND ANTIFUNGAL EAR DROPS. THE PATIENT IS A MEDICAL DOCTOR, AND SO THE HCP IS NOT SURE IF HE SAW A PHYSICIAN OR SELF PRESCRIBED THE MEDICATION HE IS TAKING. HE IS TREATING FOR OTITIS EXTERNA. THE HCP PERFORMED OTOSCOPY ON (B)(6) BUT COULD NOT VISUALIZE MUCH DUE TO PRESENCE OF MEDICATION. THE PATIENT REPORTED PAIN PRIOR TO REMOVING THE DEVICE. THERE IS NO PRIOR HISTORY OF EAR INFECTIONS. HCP REPORTED NOTHING OUT OF THE ORDINARY OR ADDITIONAL CONTRIBUTING FACTORS. (4115): LYRIC IS A SINGLE USE DEVICE AND IS NORMALLY DISCARDED AFTER USE, AND HENCE NOT AVAILABLE FOR THE ANALYSIS. (36): THE MANUFACTURER REVIEWED THE DEVICE TECHNICAL FILE, INCLUDING THE RISK FILE AND THE IFU. LYRIC IS INTENDED TO BE WORN COMPLETELY INVISIBLE IN THE EAR CANAL 24/7 FOR MONTHS AT A TIME. TO ACHIEVE THIS INTENDED APPLICATION (AND THEREWITH THE CLINICAL BENEFIT), SOFT FOAM COMPONENTS (SEALS) ARE USED IN DIFFERENT SIZES TO ENABLE AN IDEAL FIT IN AN INDIVIDUAL'S EAR CANAL. THE SEALING OF THE EAR CANAL MIGHT LEAD TO A MOISTURE ACCUMULATION IN THE VOLUME BETWEEN DEVICE AND EAR DRUM WHICH COULD LEAD TO SKIN INJURIES. THE COMPROMISED SKIN INTEGRITY, THE MOIST AND DARK ENVIRONMENT PROMOTES BACTERIAL INFECTION, WHICH COULD OCCASIONALLY CAUSE SKIN IRRITATIONS AND/ OR INFECTIONS LIKE OTITIS EXTERNA. OTITIS EXTERNA IS A COMMON EAR CONDITION, WHICH HAS AN ANNUAL INCIDENCE OF ABOUT 1% IN A REGULAR POPULATION (NON-HEARING AID WEARERS). IT MIGHT REQUIRE PROFESSIONAL MEDICAL INTERVENTION (IN MOST CASES TOPICAL ANTIBIOTICS), BUT A FULL RECOVERY IS ALWAYS EXPECTED. THEREFORE, THERE IS A STRONG REASON TO BELIEVE, THAT THE BENEFIT OF THE DEVICE OUTWEIGHS THE ASSOCIATED RISK. THE RISK MANAGEMENT FILE AND THE IFU ALREADY ADDRESS THE RISK OF INFLAMMATION, PAIN, REDNESS, AND BLISTERS. THE IFU CONTAINS APPROPRIATE PATIENT INFORMATION AND WARNINGS, INCLUDING TO CONSULT A PHYSICIAN IF THERE ARE SIGN OF INFLAMMATION OR PAIN, AND LISTS OTITIS EXTERNA UNDER THE KNOWN SIDE EFFECTS SECTION.

Description of Event or Problem

SONOVA WAS INFORMED THAT A PATIENT WHO IS A LYRIC HEARING AID USER GOT OTITIS EXTERNA.