Transcript Slide 1
Introduction to the Neuromonics Tinnitus Treatment For Candidates relief 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 relief 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 relief Pathogenesis of Tinnitus Auditory Perception Attention and Awareness Emotional Response relief Sub-Cortical Awareness Processing relief Neuromonics: Mechanism of Action Auditory Attentional Emotional 1. Perception 2. Attention 3. Reaction Stimulation Desensitization Relaxation & Relief Acoustic signal Helps retrain the brain to be less customized for each patient’s hearing profile aware and bothered by tinnitus in relaxed (stereo) state relief 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. Pleasant, relaxing music. Relief from tinnitus perception. What is Neuromonics Tinnitus Treatment? 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 relief 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 relief 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 relief Treatment Usage Treatment cannot be used when: Driving Straining to hear Listening to television Device may get wet Exercising to raise your heart rate relief 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 relief 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 relief Classical Baroque Style Contemporary/Relaxation Style Importance of Customization relief 0 2 0.25 0.5 3 4 1 2 Pitch kHz 6 7 4 6 8 8 10 9 12 Music 10 20 30 40 dB 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 1 50 60 Thresholds 70 80 90 100 110 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 relief Treatment: Stage 1 (Schematic) relief 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 2 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 Intensity (Schematic) relief Clinical Outcomes (after 6 months of treatment*): 40% + Reduction in Tinnitus Disturbance**…… 95% 40% + Reduction in Tinnitus Awareness………… 84% 5 dB + Reduction in MML***..……………………… 78% 5 dB + Improvement in LDL****..………………… 69% relief 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 …………………………. 97% Improved ability to fall asleep ………… 94% A sense of control of tinnitus …………. 94% Improved ability to relax …………………. 94% relief Davis, P, Paki, B, Hanley, P. Neuromonics Tinnitus Treatment: Third Clinical Trial. Ear and Hearing. 2007; Vol. 28, No. 2; 242-257. www.neuromonics.com relief