MAUDE Adverse Event Report: NEUROMONICS, INC. NEUROMONITCS OASIS.; TINNISU DEVICE

Model Number 200-016

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Tinnitus (2103)

Event Date 02/06/2015

Event Type  Injury  

Event Description

I began using a prescription neuromonics oasis device on (b)(6) 2014 as treatment for extreme pulsatile tinnitus in my right ear.I initially experienced some sense of relief, but volume levels were set profoundly different in each ear, the left being over driven if the master volume were set high enough to be audible in the symptomatic right ear.The internal volume settings were adjusted by the prescribing audiologist ((b)(6)) on (b)(6) 2014 and again on (b)(6) 2014.I used the device daily according to instructions (2-4 hours/day), but began to experience tinnitus at a much higher pitch, and now in both ears.On (b)(6) 2015 i bought this to the attention of the audiologist, and was advised to continue using the device as instructed.My tinnitus continued to intensify, with the addition of increasing hyperacusis.On (b)(6) 2015 i received a positive diagnosis for displacement of my right cochlear nerve by a vascular loop coursing through my right internal auditory canal.Neurosurgery was recommended, and is now scheduled for (b)(6) 2015.On (b)(6) 2015 i sought a second opinion on continuing use of the neuromonics oasis from the staff audiologist of neuromonics, inc.((b)(4)).She advised me to continue using the device as recommended.I did so, though with growing concern for my still-intensifying tinnitus and hyperacusis.On (b)(6) 2015 i again contacted neuromonics, inc's staff audiologist, and was again was advised to continue using the device.This recommendation was reaffirmed on (b)(6) 2015.On (b)(6) 2012 i concluded independently to cease using the device.As of this writing, the tinnitus now established in both ears at the pitch of a high, pulsing screech, and i find everyday sounds such as crumpling paper or children's voices extremely painful.On (b)(6) 2015, i contacted the (b)(4) of neuromonics, inc.((b)(4)).He pointedly refused to answer any questions about the device or his company's sense of responsibility, but did state that he, himself, would have recommended that i continue using it.The retailing audiologist ((b)(4)) does not provide any contract for services related to the device, which in my east was priced at (b)(4) (it is a 4-track sound generator similar in appearance to a (b)(6), and said to be specially programmed with regard to the client's audiogram).It is not possible to obtain any specific details of this prescription, however, these details being considered, "proprietary information." the (b)(4) stated that refusal to issue a contract or purchase agreement was of no concern to him before he hung up on me.He was shouting at me throughout the conversation, and frequently interrupted me to restate his refusal to answer my questions.I have concluded that this device has done me serious harm, and is potentially harmful to a select group of other clients who may not have been singled out by a differential diagnosis.It is marketed according to a one-size-fits-all model with the claim that it is incapable of doing harm under any circumstances of use.It is a class ii medical device that received fda clearance.The marketing company's press releases states it to be fda approved.

• Brand Name: NEUROMONITCS OASIS.
• Type of Device: TINNISU DEVICE
• Manufacturer (Section D): NEUROMONICS, INC.
• MDR Report Key: 4577738
• MDR Text Key: 21832508
• Report Number: MW5041242
• Device Sequence Number: 1
• Product Code: KLW
• 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: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 200-016
• Device Lot Number: REV. 2
• Other Device ID Number: 01D000C0502
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 54