PHONAK LYRIC4

Description of Event or Problem

IT HAS BEEN BROUGHT TO MANUFACTURER'S ATTENTION THAT LYRIC DEVICE WAS REMOVED AFTER 8 WEAR DAYS DUE TO DISCOMFORT AND EAR IRRITATION. UPON THE REMOVAL THE PATIENT WAS REPORTING MUFFLED HEARING AND SIGNIFICANT RIGHT-SIDED TINNITUS. HCP OBSERVED SIGNIFICANT OFF-WHITE DEBRIS OCCLUDING EAR CANAL, SUSPECTED POSSIBLE INFECTION. PATIENT WAS REFERRED TO ENT BEFORE REPLACING RIGHT LYRIC. FOLLOW UP WITH THE HCP HAS BEEN INITIATED TO ACQUIRE MORE INFORMATION ABOUT THE EVENT.

Additional Manufacturer Narrative

(4112) THE MANUFACTURER CONDUCTED A FOLLOW UP WITH THE INITIAL REPORTER. THE HCP REPORTED THAT THE PT WAS SEEN BY ENT WHO SAW SIGNS OF INFECTION AND RECOMMENDED EARDROPS. PT IS AN EXPERIENCED LYRIC USER, WHO CAN REMOVE LYRIC THEMSELVES AND DID SO WHEN DISCOMFORT STARTED. WITH A SECOND FOLLOW UP A COUPLE OF DAYS LATER, THE MANUFACTURER AS LEARNED FROM THE HCP THAT THE INFECTION WAS CLEARED UP AND THE ENT HAS CLEARED THE PATIENT TO BE FITTED WITH LYRIC AGAIN. THE PATIENT WAS TREATED WITH EAR DROPS, SO THE HCP ASSUMES DX WAS OTITIS EXTERNA. THE HCP FIT THE PATIENT WITH A DEVICE ONE SIZE LARGER, IN ATTEMPT TO MINIMIZE MOISTURE INTRUSION INTO THE CANAL. THE HCP REPORTS THE PATIENT HAD ALREADY TINNITUS, BUT IT WORSENED WHEN THE DEVICE WAS REMOVED THE HCP BELIEVES THIS WAS RELATED TO THE DEBRIS IN THE CANAL AND OTITIS EXTERNA. AFTER THIS WAS TREATED, THE HCP REPORTS THAT THE TINNITUS HAS GONE BACK TO BASELINE FOR THIS PATIENT. (4115) LYRIC IS A SINGLE USE DEVICE AND IS USUALLY DISCARDED AND HENCE IS NOT AVAILABLE FOR THE ANALYSIS. THE DEVICE IS DESIGNED TO BE WORN DEEP WITHIN THE EAR CANAL, EFFECTIVELY SEALING IT AS INTENDED. HOWEVER, THIS SEALING CAN POTENTIALLY LEAD TO MOISTURE ACCUMULATION IN THE SPACE BETWEEN THE DEVICE AND THE EARDRUM. SUCH MOISTURE RETENTION MAY COMPROMISE SKIN INTEGRITY, CREATING A MOIST AND DARK ENVIRONMENT THAT IS CONDUCIVE TO BACTERIAL GROWTH. THIS ENVIRONMENT CAN OCCASIONALLY RESULT IN SKIN IRRITATIONS 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. (36) THE MANUFACTURER HAS REVIEWED THE TECHNICAL FILE OF THE DEVICE. EAR INFECTION AND OTHER SYMPTOMS RELATED TO THE DEEP INSERTION OF LYRIC HAVE ALREADY BEEN CONSIDERED IN THE DEVICE'S CLINICAL EVALUATION REPORT AND RISK FILE. THE ACCOMPANYING IFU LISTS ACTIONS TO TAKE WHEN EAR PAIN, IRRITATION OR INFLAMMATION OCCURS AND TO SEEK MEDICAL ADVICE. IT SHOULD BE ALSO NOTED THAT OTITIS EXTERNA IS A RELATIVELY COMMON CONDITION THAT CAN OCCUR INDEPENDENTLY OF HEARING AID USE AND A FULL RECOVERY IS EXPECTED. (4109) THE MANUFACTURER CHECKED FOR SIMILAR COMPLAINTS IN THE LAST THREE YEARS AND THERE IS NO GLOBAL MARKET TREND OBSERVED FOR THIS ISSUE. THE MANUFACTURER WILL KEEP OBSERVING FOR TRENDS. THIS IS THE FINAL REPORT.