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Introduction to the Neuromonics Tinnitus Treatment For Candidates. Neuromonics Background. Core technology conceived in 1993 Neuromonics formed in 2001 Current locations; Bethlehem, PA & Sydney, Australia Randomized clinical trials with >200 tinnitus patients
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Introduction to the Neuromonics Tinnitus Treatment For Candidates
Neuromonics Background • Core technology conceived in 1993 • Neuromonics formed in 2001 • Current locations; Bethlehem, PA & Sydney, Australia • Randomized clinical trials with >200 tinnitus patients • Thousands of patients treated worldwide • FDA clearance 2005 • Regulatory approval in: United States, Australia, New Zealand and Singapore
Tinnitus Population 50 Million suffer from tinnitus 10-15 Million seek medical treatment for tinnitus 2 Million have severe, highly disturbing tinnitus 1 Million new cases of tinnitus are identified per year 400,000 Veterans on tinnitus disability
Pathogenesis of Tinnitus Auditory Perception Attention and Awareness Emotional Response
Neuromonics: Mechanism of Action Auditory Attentional Emotional 1. Perception 2. Attention 3. Reaction Stimulation Relaxation & Relief Desensitization Pleasant, relaxing music. Relief from tinnitus perception. Acoustic signal customized for each patient’s hearing profile (stereo) Helps retrain the brain to be less aware and bothered by tinnitus in relaxed state Hanley PJ, Davis PB. Treatment of tinnitus with a customized, dynamic acoustic neural stimulus: underlying principles and clinical efficacy. Trends in Amplification. 2008; Sep;12(3):210-22. Epub 2008 Jul 9.
Non-invasive, FDA cleared, patented and clinically tested Proven long-term reduction of tinnitus disturbance Clinically administered and monitored by a trained clinician Combines a novel approach to acoustic stimulation with structured counseling and support What is Neuromonics Tinnitus Treatment?
Neuromonics Tinnitus Treatment • Treatment signal and music is customized to your hearing profile • Decreases awareness and disturbance to the tinnitus • Treatment duration is generally 6 - 8 months but can vary depending on your individual case
Treatment Usage • Required usage is 2 - 4 hours per day when the tinnitus is most bothersome • Can use in small segments of time during the day • For example: 15, 30 or 60 minute time intervals • Device tracks usage throughout the day
Treatment Usage Treatment cannotbe used when: • Driving • Straining to hear • Listening to television • Device may get wet • Exercising to raise your heart rate
Appointment Schedule • Fitting of your customized device • Periodic follow-ups to monitor progress approximately every 8 to 10 weeks • Retest measurements as needed • Download logged data from device • Final appointment
Treatment Stimulus • Treatment signal is a customized stimulus which is embedded in music • Music mimics the resting heart rate to help with relaxation • Specially chosen for its frequency response to maximize stimulation of the auditory pathways • Styles of music used • Classical Baroque Style • Contemporary/Relaxation Style
kHz 1 2 3 4 6 7 8 9 0.25 0.5 1 2 4 6 8 10 12 0 10 Music 20 30 40 50 dB 60 70 Thresholds 80 90 100 110 Importance of Customization Pitch • Maximize stimulation of the auditory pathways • Stereo effect- balances right and left ear • Allows for more relief from tinnitus at a lower listening volume • Able to use treatment for sleep • Helps with relaxation Loudness Spectral Composition of Music + Hearing Thresholds of Typical Clinic Patient Sample
Device • Easy to use • Volume control allows you to set at a comfortable level • Monitors daily and cumulative usage • Rechargeable battery
The first stage is designed to help you get relief from the tinnitus while using the treatment and also to help you relax High level of interaction Relief and reduction of tinnitus awareness during listening sessions Treatment: Stage 1 (Schematic)
The purpose of the second stage of treatment is to help re-train your brain to be less aware and less bothered by the tinnitus Intermittent interaction with tinnitus See results even when not using the treatment Treatment: Stage 2 Intensity (Schematic)
Clinical Outcomes(after 6 months of treatment*): 40% + Reduction in Tinnitus Disturbance**…… 40% + Reduction in Tinnitus Awareness………… 5 dB + Reduction in MML***..……………………… 5 dB + Improvement in LDL****..………………… 95% 84% 78% 69% Davis, P, Paki, B, Hanley, P. Neuromonics Tinnitus Treatment: Third Clinical Trial. Ear and Hearing. 2007; Vol. 28, No. 2; 242-257. *Clinical measures reported by participants with significant levels of tinnitus disturbance prior to treatment. **Measured by the Tinnitus Reaction Questionnaire ***Participants with pretreatment minimum masking level of greater than 5dB ****Participants with decreased sound tolerance
Patient Satisfaction Relief from tinnitus …………………………. Improved ability to fall asleep ………… A sense of control of tinnitus …………. Improved ability to relax …………………. 97% 94% 94% 94% Davis, P, Paki, B, Hanley, P. Neuromonics Tinnitus Treatment: Third Clinical Trial. Ear and Hearing. 2007; Vol. 28, No. 2; 242-257.