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Patient 1
DURING THE USE OF THE HEARING AID BELTONE TST963 -MODEL, CATALOG NO 19705405, THE USER EXPERIENCED THE FOLLOWING: EAR STARTED TO ITCH, HURT AND BECAME INFLAMED WITHIN 24 HOURS OF USE. SYMPTOMS WAS IN EAR CANAL. SINCE THE HEARING AID IS EQUIPPED WITH A DOME AND THE DOME IS PLACED INTO THE EAR CANAL, THE ISSUE RELATES TO THE DOME AND NOT TO THE HEARING AID ITSELF. MD PRESCRIBED OINTMENT AND ANTIBIOTIC. PATIENT DISCONTINUED THE USE OF THE HEARING AIDS FOR 7-10 DAYS AND REACTION REOCCURRED WHEN TRYING WEARING THEM A SECOND TIME. ALLERGIC REACTION IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED TO AN ACCEPTABLE LEVEL THOUGH DEVICE DESIGN IN COMPLIANCE WITH STANDARDS FOR BIOLOGICAL-COMPATABILITY. STILL ALLERGIC REACTIONS CAN OCCUR IN RARE CASES. THE CLINICAL EVALUATION DOES EVALUATE ALLERGIC REACTIONS AND THE USER GUIDE INCLUDES A SAFETY NOTIFICATION INSTRUCTING THE HEARING AID WEARER TO CONTACT THE HPC IN CASE OF SKIN IRRITATION. CLINICAL CONCLUSION ON THE CASE IS THAT IT CANNOT BE EXCLUDED THAT THE DEVICE (THE DOME) HAVE BEEN CAUSING OR CONTRIBUTING TO THE SKIN REACTION AND THAT THE REACTION REQUIRED MEDICAL INTERVENTION (OINTMENT AND ANTIBIOTICS). NO LUBRICANT WAS USED DURING THE FITTING OF THE HEARING AID AND DOME. THE PATIENT IS CURRENTLY NOT WEARING ANY HEARING AID.