MAUDE Adverse Event Report: NEUROMONICS INC. NEUROMONICS OASIS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hearing Impairment (1881)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The reporter stated that she was suffering from tinnitus in her right ear.Her audiologist prescribed neuromonics oasis to alleviate the symptoms.The reporter stated that she suffered from adverse effect using the device.She is experiencing loud screeching noises and the pitch was very loud.After wearing the device, both of her ears became affected.The reporter also complained that her audiologist did not give her a prescription for the device.The reporter stated as a result fo this condition, she has not been able to function normally for the past thirteen months.She has stopped working, and has not been able to go to public places since the surrounding noise is too loud for her.

• Brand Name: NEUROMONICS OASIS
• Type of Device: NEUROMONICS OASIS
• Manufacturer (Section D): NEUROMONICS INC.
• MDR Report Key: 4541670
• MDR Text Key: 15106042
• Report Number: MW5040884
• 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: Other
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Weight: 53