MAUDE Adverse Event Report: EARLENS CORPORATION HEARING AIDS (LEFT); TYMPANIC MEMBRANE DIRECT CONTACT HEARING AID

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2022

Event Type  malfunction  

Event Description

I purchased a earlens brand right and left hearing aid through my audiologist.I had many problems with the devices not amplifying sound.I made many trips to my audiologist to have them repaired and she sent them in several times to the manufacturer.Earlens told me they would make it right and convinced me to keep the product past the return period to give them time to fix them.They were unable to fix the problem and only refunded part of my money after i returned them because they were out of the return period.My audiologist told me that in her experience over 25% of her customers with this brand experience similar issues.Please look into this company and their defective products.Thanks.Reference report: mw5146974.

• Brand Name: HEARING AIDS (LEFT)
• Type of Device: TYMPANIC MEMBRANE DIRECT CONTACT HEARING AID
• Manufacturer (Section D): EARLENS CORPORATION
• MDR Report Key: 17948865
• MDR Text Key: 326021250
• Report Number: MW5146975
• Device Sequence Number: 1
• Product Code: PLK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White