MAUDE Adverse Event Report: NANO HEARING TECH OPCO, LLC. NANO-CIC-RECHARGE-JH-R/B; HEARING AID, AIR-CONDUCTION, OVER THE COUNTER

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

We purchased nano hearing aids on (b)(6) 2022 received them (b)(6) 2022.We are retired and my husband wanted to try these based on commercials and the fact they advertised 45 day full refund if not completely satisfied.They did not help his hearing one bit.He only wore them twice.I got an ra# from nano rma: (b)(4), boxed them exactly like we got them, same container, box, all booklets, accessories.We send them back and heard no word from them at all.After i started emailing them they told me that the left one was received damaged and we would not be getting back our (b)(6) (includes tax) actual price was (b)(6).They accused me of damaging them.They were not damaged! they were in perfect condition, he again only wore them twice.I believe they damaged them purposely so they don't have to return the money.We did nothing to damage them.I filed a complaint with the bbb, they then told the bbb the same lie about being damaged and they offered us another paid.The first pair didn't work, why would i want another pair? then on (b)(6) 2022 i filed a complaint with the (b)(6) office of attorney general (b)(6) and they strongly suggested we also file a complaint with the fda, (b)(6) dept of health and federal trade commission.This company is falsely advertising their product.They claim a full refund within 45 days of purchase, i believe they intentionally damaged the hearing aids.There are many complaints on this company.Nano hearing aids, (b)(4).

• Brand Name: NANO-CIC-RECHARGE-JH-R/B
• Type of Device: HEARING AID, AIR-CONDUCTION, OVER THE COUNTER
• Manufacturer (Section D): NANO HEARING TECH OPCO, LLC.; 1761 s mojave road; ste b; las vegas NV 89104
• MDR Report Key: 16086067
• MDR Text Key: 306621740
• Report Number: MW5114112
• 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: 12/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White