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Introduction to the Neuromonics Tinnitus Treatment

For Candidates

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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

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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

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Pathogenesis of Tinnitus

Auditory Perception

Emotional Response

Attention and Awareness

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Sub-Cortical Awareness Processing

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Neuromonics: Mechanism of Action

3. Reaction1. Perception 2. Attention

EmotionalAuditory Attentional

Stimulation Desensitization Relaxation & Relief 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

Pleasant, relaxing music.

Relief from tinnitus perception.

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.

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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?

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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

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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

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Treatment Usage

Treatment cannot be used when: Driving Straining to hear Listening to television Device may get wet Exercising to raise your heart rate

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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

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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

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Importance of Customization

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

0.25 0.5 1 2 4 6 8 10 120

10

20

30

40

50

60

70

80

90

100

110

1 2 3 4 6 7 8 9

dB

kHz

Thresholds

Music

Spectral Composition of Music +Hearing Thresholds of Typical

Clinic Patient Sample

Loud

ness

Pitch

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Device

Easy to use

Volume control allows you to set at a comfortable level

Monitors daily and cumulative usage

Rechargeable battery

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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)

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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

Treatment: Stage 2

(Schematic)

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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

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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.

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www.neuromonics.com