MAUDE Adverse Event Report: NANO HEARING AID NANO HEARING AID; HEARING AID, AIR-CONDUCTION, OVER THE COUNTER

Model Number RX 2000 BEHIND THE EAR

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2023

Event Type  Death  

Event Description

My mother purchased these hearing aids on (b)(6) 2021 and received them (b)(6) 2021.She became very ill and never used the hearing aids, and was too sick to send them back and request a refund.She became increasingly ill and ended up under hospice care and passed away.I'm her daughter and executor and found the hearing aids while cleaning out her house.The nano hearing aids were still in the original box and therefore never used.Since they were never used i gave them to someone who could benefit from the use of hearing aids.It was then discovered that the left hearing aid didn't work.I immediately called nano and they said to ship the hearing aid back to them, and they would inspect the defective hearing aid.I received an email stating they received the hearing aid but never received a follow up as to how the case was being handled.I called nano on (b)(6) 2023 and was told the hearing aid was defective, and if i paid them (b)(6) processing fee they would send me another hearing aid.Since my mother had initially paid (b)(6) for a defective hearing aid i refused to pay another (b)(6).They kept insisting this was their policy.My mother was not a wealthy woman and lived solely on social security.I'm also not wealthy and will not pay another (b)(6) to a company that is clearly selling cheap defective hearing aids, and taking advantage of the senior citizen population promising something they can't deliver which is a functioning product.They are also comparing them to medical grade hearing aids and that is false misleading advertising.Especially to the older more trusting senior population.Obviously the product does not go through a quality assurance process because if it did, it would have been discovered the hearing aid did not work as it should and promised to the consumer who was my mother.Please help me resolve the issue with this company that is taking advantage of our senior citizens.I'm only requesting to receive what my mother ordered & paid for which is working hearing aids without paying additional monies towards the replacement (b)(6).I believe this request shows what a dishonest company nano is.Please note, i do not have a copy of a receipt, since these were purchased on my mother's credit card.Thank you.

• Brand Name: NANO HEARING AID
• Type of Device: HEARING AID, AIR-CONDUCTION, OVER THE COUNTER
• Manufacturer (Section D): NANO HEARING AID; 511 s royal ln; coppell TX 75019
• MDR Report Key: 16861086
• MDR Text Key: 314537830
• Report Number: MW5117207
• Device Sequence Number: 1
• Product Code: QUF
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: RX 2000 BEHIND THE EAR
• Device Catalogue Number: NANO RX 2000 ACC B
• Device Lot Number: NANO RX2000 B
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White