MAUDE Adverse Event Report: INTRICON CORPORATION LEXIE LUMEN; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Catalog Number	93336-009
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687); Ear Pain (4812); Ear injury (4921)
Date of Event	09/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bought through walgreen's.Following the steps in the "say hello to your lexies" booklet, i used a 2b slim tube and tulip dome.Length was correct per ear measurement card.I put the hearing aid on and put the dome just inside the ear.I very, very lightly tapped the slim tube which pushed the dome into my ear.I figured this was how it was supposed to be.I put the other one on the same as the first.I couldn't get the aides to connect to my iphone's bluetooth.So, i went to take them out to check the battery placement.When i gently tugged on the slim tube closest to the dome.The slim tube came out; the dome did not - on either side.I could not reach far enough in to remove the domes.My husband tried but could not see the dome to try to reach it in either ear.I went to an immediate care.They could see the domes but were unsuccessful with long tweezers (extremely painful) and sent me to the emergency room.They used alligator forceps and were able to remove the domes from both ears.Excruciatingly painful removal! i was given topical antibiotics as my left eardrum was bleeding from the digging, scraping and difficult removal.Hospital kept the domes to throw away.I do still have the rest of the product.Reference report: mw5176271.

• Brand Name: LEXIE LUMEN
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): INTRICON CORPORATION
• MDR Report Key: 23107946
• Report Number: MW5176272
• Device Sequence Number: 18666013
• Product Code: OSM
• UDI-Device Identifier: 00858177007540
• UDI-Public: (01)00858177007540(11)220222
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 93336-009
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADDERALL. ; CYMBALTA.; D3.; K2.; LAMOTRIGINE.; METFORMIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Race: White