1. Neuromonics Tinnitus Treatment
Introduction to the
Neuromonics Tinnitus Treatment
For Candidates

2. 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
The Neuromonics Story in a nutshell – Dr Paul Davis conceived the idea in the early 1990s. He wrote to all the universities in Australia who were offering Audiology and received an acceptance from Curtin University in Perth to do some research. That was the start.
Three clinical trials were conducted at Curtin University with over 200 participants. A fourth independent clinical trial was conducted under the supervision of Prof Phillip Newall at Macquarie University.
In 2001 Neuromonics the company was formed.
FDA clearance in early these regulatory bodies require us to provide the product and hence treatment in a very consistent and quality controlled manner
And we became available to market in the U.S. in early 2007.
Headquarters in Bethlehem, Pennsylvania, USA and another office in Sydney, Australia. 2 2

3. 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 3

4. Attention and Awareness
Pathogenesis of Tinnitus
Auditory Perception
Attention and Awareness
Emotional Response

5. Sub-Cortical Awareness Processing
This slide may be useful for some clients to illustrate the role of subconscious filter in the auditory pathway. Below are some potentially useful analogies
Many sounds enter the subconscious filter however they don’t always reach the conscious area of the brain i.e. we are not aware of all these sounds (you may like to relate an example to the client, choose the most appropriate or feel free to add one of your own)
E.g. (1) Mother of a new born may be sound asleep at night when a fierce storm begins and she can remain fast asleep. In this instance the subconscious filter determines that the storm sound isn’t important and the sound is put in the “other brain centres” or the junk pile. However if her baby starts crying she is up in a flash. In this instance the subconscious filter assigns this sound as important and the mother is instantly aware
E.g (2) You may be at a party in a crowded room happily talking to someone. Everyone else is speaking and their voices are placed in the “other brain centres”, however someone on the other side of the room may say your name and you’re aware of your name straight away. Again the subconscious filter assigns your name as a significant sound signal
This importance that the subconscious filter places on sounds can change.
E.g. (1) People move next to a train line and can’t get to sleep at night, after a while they don’t notice the train (the sound is no longer important)
E.g. (2) People buy new fridges and can’t get to sleep at night but again after a while they no longer notice the fridge
Imagine there is a tiger next to you in the clinic slightly purring away, despite my best efforts to talk to you it is reasonable to assume that you wouldn’t be able to concentrate on what I was saying because of the purr of the tiger would be taking all of your attention – Why? Because that sound is classified as VERY important
ADP treatment aims to reduce the significance that is attached to the tinnitus by the subconscious filter or areas of the brain. Once this occurs the awareness and the disturbance is reduced.

6. Neuromonics: Mechanism of Action
Auditory
Attentional
Emotional
1. Perception
2. Attention
3. Reaction
Stimulation
Desensitization
Relaxation & Relief
Acoustic signal customized for each patient’s hearing profile (stereo)
Pleasant, relaxing music.
Relief from tinnitus perception.
Helps retrain the brain to be less aware and bothered by tinnitus in relaxed state
Hanley & Davis, in press – Trends in Amplification
Mechanism of action of the Neuromonics Tinnitus Treatment
Discrete aspects of the Neuromonics Tinnitus Treatment address each of the neural processes outlined above.
Auditory stimulation to address the effects of auditory deprivation: Neuromonics delivers a broad frequency stimulus into the system that’s been deprived of stimulation and thereby counters the need for increased auditory sensitivity. Studies have shown that neuronal changes that result from hearing damage can be reversed by feeding sound into the auditory system[1]. In the Neuromonics treatment, this is achieved through the use of a wide frequency stimulus that is spectrally modified to account for each patient’s hearing loss profile. This modification is performed separately for each ear and the resultant stimuli combined in a way which provides balanced perception across the two ears, and is delivered in stereo to stimulate the integrative pathways of the auditory system. In this way, the treatment stimulates as much of the system as possible as evenly as possible, and thereby reduces the need for the brain to ‘turn up’ the sensitivity in the auditory system.
Relaxation and relief to address the aversive reaction / stress response: a key part of the Neuromonics stimulus is relaxation music, which addresses the limbic system / autonomic nervous system involvement that causes the aversive reaction to the tinnitus. This aspect of the treatment draws upon studies that have shown that relaxation music is as effective as progressive muscle relaxation in generating a relaxation response[2]. This benefit is further reinforced by the relief and sense of control that comes from being able to shut out the tinnitus sound (perhaps for the first time in years), as well as by improvements in sleep that commonly result from treatment. The combination of relaxation, relief and improved sleep lead to a reduction in the level of limbic system arousal and the consequential stress response.
Systematic desensitization to address the perceptual filters that lead to attention to the tinnitus: in the context of the relaxation response, Neuromonics addresses the attentional filters using the principles of systematic desensitization. Because of the dynamics of the music, once customized for the patient’s profile and delivered in a tightly controlled way, the stimulus allows the patient to cover the tinnitus in the peaks of intensity in the music, while allowing the tinnitus to be momentarily perceived in the intensity troughs. In this way, the brain experiences repeated, momentary perception of the tinnitus whilst in a relaxed state. By gradually increasing the degree of exposure to the tinnitus perception over time, the brain is ‘retrained’ to perceive the tinnitus sound but not to pay particular attention to it, and not to trigger the stress response in reaction to it.
[1] Norena, A.J. & Eggermont, J. (2005). Enriched Acoustic Environment after Noise Trauma Reduces Hearing Loss and Prevents Cortical Map Reorganization. The Journal of Neuroscience, 25:
[2] Stoudenmire, J. (1975). A comparison of muscle relaxation training and music in the reduction of state and trait anxiety. Journal of Clinical Psychology, 31: ; Kibler, V.E. & Rider, M.S. (1983). The effect of progressive muscle relaxation and music on stress as measured by finger temperature response. Clinical Psychology, 39:
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): Epub 2008 Jul 9.

7. 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
A treatment regimen consisting of:
novel & patented acoustic therapy
individually prescribed for each patient (compensation for hearing loss)
provided via a portable device
plus education & counseling
from a specialist clinician 7 7

8. Neuromonics Tinnitus Treatment
Treatment signal and music is customized to your hearing profile
Decreases awareness and disturbance to the tinnitus
Treatment duration is generally months but can vary depending on your individual case

9. Treatment Usage
Required usage is 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

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

11. 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

12. 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

13. Importance of Customization 10 20 30 40 50 60 70 80 90
100
110 1 2 3 4 6 7 8 9 dB
kHz
Thresholds
Music
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

14. Device
Easy to use
Volume control allows you to set at a comfortable level
Monitors daily and cumulative usage
Rechargeable battery

15. Treatment: Stage 1
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
(Schematic) 15

16. 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)
Really cover the idea that exposure to tinnitus is necessary for active treatment 16

17. 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;
*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 17

18. Patient Satisfaction Relief from tinnitus ………………………….
Improved ability to fall asleep …………
A sense of control of tinnitus ………….
Improved ability to relax ………………….
97%
94%
Davis, P, Paki, B, Hanley, P. Neuromonics Tinnitus Treatment:
Third Clinical Trial. Ear and Hearing. 2007; Vol. 28, No. 2; 18