NEUROMONICS OASIS TINNITUS TREATMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-06 for NEUROMONICS OASIS TINNITUS TREATMENT manufactured by Neuromonics.

Event Text Entries

[16103893] Subject: neuromonics - oasis treatment for tinnitus sufferers. This device exacerbated the tinnitus and it has never returned to previous level. It was prescribed by dr (b)(6) of (b)(6). (b)(6) has suffered untold agony from the exacerbation of the tinnitus noise caused by this device. It has been returned to the company, neuromonics, inc. And money has been refunded for the device itself, but not for physician charges. This report is being filed to hopefully prevent someone else from becoming a victim to this medical. Neuromonics non-invasive device, customized to each pt's individual audiological profile, delivers a neural stimulus that targets the brain's auditory pathways. Clinically administered and monitored, the treatment is a therapy delivered through a compact, lightweight device. Targeting the neurological processes of tinnitus - specifically its audiological, attention-based and emotional aspects. Ntt typically occurs over an approx six-month period, with daily use recommended for two or more hrs per day. Research published in the april 2007 issue of ear and hearing demonstrates that the treatment yields clinically significant reduction in tinnitus disturbance for more than 90 percent of suitable pts. Wear 4 - 6 hrs per day. Dates of use: (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5027564
• MDR Report Key: 2830170
• Date Received: 2012-11-06
• Date of Report: 2012-11-06
• Date of Event: 2012-05-15
• Date Added to Maude: 2012-11-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NEUROMONICS OASIS TINNITUS TREATMENT
• Generic Name: OASIS
• Product Code: KLW
• Date Received: 2012-11-06
• Returned To Mfg: 2012-06-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEUROMONICS
• Manufacturer Address: BETHELEHEM PA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2012-11-06