desyncra for tinnitus professional brochure

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CR ® Neuromodulation | The Scientific SOLUTION

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Page 1: Desyncra for Tinnitus Professional Brochure

CR® Neuromodulation | The Scientific SoluTioN

Page 2: Desyncra for Tinnitus Professional Brochure

2 | CR® Neuromodulation | The Scientific SoluTioN | 3Discover more at desyncra.com

Long Lasting ReliefPatients report improved symptoms, including reduced loudness and annoyance.

Similarly, clinical studies show significantly improved tinnitus questionnaire results, representing relief from tinnitus and improved quality of life.

› Further details at Williams et al. Front. Neurol. 2015

Reduced Loudness and Annoyance (VAS Scores)

Before Therapy 24 Weeks

80

70

60

50

40

30

20

n=66

62

46 46

68

Loudness Annoyance

VA

S Sc

ores

Acute and Long-Term EffectsThe acute effect reduces symptoms as the patient is receiving the therapy tones. More importantly, there is a sustained effect that persists beyond active stimulation.

Sustained relief through long lasting changes in neuronal behavior

As therapy progresses, the brain plasticity enables long term benefits that persist beyond the therapy period.

› Further details at Tass et al. Restor. Neurol. Neurosci. 2012

Loudness

TreaTmenT80

70

60

50

40

30

200 4 12 16

n=22 Acute Effect Sustained Effect

VA

S Sc

ores

Neurotherapy on an iPod

Comfort and ConveniencePatients wear the device for between 4 and 6 hours per day (minimum 1 hour sessions) over a 36 week period.

Therapy on the go

The therapeutic tones are quiet yet audible, allowing patients to continue with everyday activities.

Sustained Changes in Neuronal BehaviorDesyncra™ for Tinnitus is designed to change the patterns in neural tinnitus networks. The patient’s improved symptoms are reflected in EEG imaging, showing reduced delta wave activity across neuronal networks.

Brain imaging shows reduced delta wave activity

Tinnitus is associated with elevated delta wave activity and a reduction of the hyperactivity in these brain waves is observed after Desyncra™ for Tinnitus therapy.

› Further details at Adamchic et al. HBM 2014

Desyncra™ for Tinnitus offers a unique, scientific solution to tinnitus. The noninvasive, targeted therapy is designed to change the patterns in neural tinnitus networks, and reduce the tinnitus symptoms.

Over 3,000 patients treated

The Desyncra™ therapy is delivered using a customized iPod device with custom designed earphones. The therapeutic tones are tailored to the patient’s exact tinnitus profile.

Before After

Desyncra™ for Tinnitus uses a proprietary pitch matching procedure to achieve great accuracy. This precision in pitch matching is key to targeting the synchronized, hyperactivity in the auditory cortex.

› Further details at Hauptmann et al. JAAA 2016

Exceptionally Accurate Pitch MatchingManual Method Adaptive Method

40

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-20

-40

0 2k 4k 6k 8k 10k 0 2k 4k 6k 8k 10k

Frequency of test tone [KHz] Frequency of test tone [KHz]

40

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-20

-40

Rel

ativ

e m

ism

atch

[%]

Rel

ativ

e m

ism

atch

[%]

40% of matched inside 5% interval

80% of matched inside 5% interval+ - + -

Page 3: Desyncra for Tinnitus Professional Brochure

4 | CR® Neuromodulation | The Scientific SoluTioN | 5Discover more at desyncra.com

CR© NeuromodulationRecent developments in neuroscience have led to a clearer understanding of the neuronal activity behind tinnitus.

CR© Neuromodulation disrupts and desynchronizes hyperactivity

The Desyncra™ for Tinnitus therapy applies CR© Neuromodulation technology to disrupt and “desynchronize” the pathological, neuronal behavior. Initially a partially synchronized state is achieved, and ultimately a non-synchronized or “desynchronized” state emerges as the therapy continues. The therapy utilizes the brain’s neuronal plasticity to enable long lasting benefits.

Beyond TinnitusCR© Neuromodulation therapy offers solutions beyond tinnitus to other neurological pathologies, including Parkinson’s disease, epilepsy and migraine.

The conditions are all characterized by pathological, synchronized hyperactivity of neuronal cells in key areas of the brain. The mode of delivery is quite different for each of these neurological conditions. Yet in each case, Desyncra™ CR© Neuromodulation is designed to disrupt this synchronized activity and reduce the patient’s symptoms.

Parkinson’s TreatmentParkinson’s disease can currently be treated with deep brain stimulation and conventional neuromodulation. Typically deep brain stimulation is achieved through an implanted electrode and an external therapy device.

This approach works well and successfully manages symptoms such as trembling. However, CR© Neuromodulation has been found to deliver more sustained benefits

CR© Neuromodulation is designed to deliver benefit beyond the active stimulation

Standard devices typically only suppress symptoms such as trembling when the device is active (switched on). When switched off, the symptoms quickly return.

CR© Neuromodulation is designed to provide long lasting benefit that is sustained after the therapy device has been switched off.2 Similarly, Desyncra™ for Tinnitus is designed to change patterns in tinnitus neural networks that last beyond the 36 week therapy period.

2. Tass et al. Annals Neurol. 2012

Targeting the TinnitusThe primary auditory cortex is organized according to the pitch of sounds that are perceived, in a similar manner to the tonotopic organization within the cochlea. Neuroscientific research1 has revealed how the neuronal hyperactivity behind tinnitus can be observed in the auditory cortex in regions relating to the frequency of the patient’s tinnitus.

As the pathological, synchronized, neuronal behavior develops, the neighboring regions in the auditory cortex act in sympathy with the hyperactive area. This synchronized behavior is perceived by patients as tinnitus.

1. Adamchic et al. Human Brain Mapping 2014

Synchronized Partially Synchronized DesynchronizedSynchronized Partially Synchronized Desynchronized

Primary Auditory Cortex

Secondary Auditory Cortex

Coresponds to apex of cochlea

Coresponds to base of cochlea

0.51 2 4 8 16

No Therapy No Benefit

No Therapy No Benefit

Therapy active Accute Benefit

Therapy active Accute Benefit

After Therapy Sustained Benefit

After Therapy No Benefit

Desyncra™

Standard

Page 4: Desyncra for Tinnitus Professional Brochure

6 | CR® Neuromodulation | The Scientific SoluTioN | 7Discover more at desyncra.com

Audiologist Administered TherapyDesyncra™ for Tinnitus offers a 36 week therapy schedule with an initial fitting appointment followed by five follow-up sessions at 3, 8, 12, 24 and 36 weeks.

Follow-up sessions ensure continually optimized treatment

The initial fitting session includes loudness and pitch discrimination to ensure the patient is able to identify the frequency of their tinnitus tone.

36 week therapy, with follow-ups after 3, 8, 12, 24 and 36 weeks

Simple to ProgramProgramming the Desyncra™ for Tinnitus device is a simple procedure.

Programming is a simple 3-step process

Once the Bluetooth dongle and the Desyncra™ for Tinnitus software are installed on the audiologist’s pc computer, the patient device is turned on and the 3-step programming process can begin.

STEP 1: The audiologist ensures that the candidate can distinguish between differences in loudness and differences in pitch. Pitch discrimination testing is included in the Desyncra™ for Tinnitus software.

STEP 2: The patient and audiologist use the Desyncra™ for Tinnitus software to identify the exact pitch of the patient’s tinnitus. This is a multistep process using bracketing, similarity testing and fine tuning.

STEP 3: Once the pitch has been identified, the program is set to deliver the appropriate algorithm. The software then balances the loudness to ensure an optimized and comfortable therapy.

The step by step Programming Guide walks the audiologist and patient through the programming process.

Desyncra EarphonesThe Desyncra™ earphones are designed to deliver the therapy tones across a wide frequency range.

They are available in different sizes to ensure a comfortable and secure fit inside the ear canal.

Integrated Tinnitus QuestionnairesPeriodic follow-up sessions also provide an opportunity to track any changes in the patient’s tinnitus as reported in outcome questionnaires. Typically patients complete the questionnaire just before the fitting and follow-up sessions.

Questionnaires are included on the patient’s device and the patient may complete this activity without the need for professional guidance.

PC with Audiologist Patient Bluetooth Dongle

Desyncra™ for Tinnitus Mobile Device

Customized earphones

36 Weeks

A B B B B B

A B Follow-UpInitial Fitting

Duration 90 Minutes 60 Minutes

Loudness & Pitch Discrimination

Pitch Match & Programming

Diagnostic Questionnaires

Page 5: Desyncra for Tinnitus Professional Brochure

TI16-0113_Letter_E16-00

Research DrivenThe efficacy of Desyncra™ for Tinnitus is reflected in the quality and quantity of published research.

Clinical studies involving hundreds of patients have been published to date. These studies include both prospective and retrospective trials, and include insubject and placebo controls.

Discover more at desyncra.com

Desyncra Inc 1137 Pearl St #201 Boulder,CO 80302 United States

Office: 720-389-0669 Toll Free: 844-444-2266

[email protected]

Desyncra™ for Tinnitus has FDA clearance and carries the CE Mark.

Future Clinical TrialsDesyncra for Tinnitus is commited to further research as is demonstrated by forthcoming studies:

CR© Neuromodulation administered during sleep

CR© Neuromodulation delivered through hearing aids

Algorithm development to further strengthen performance

Worldwide Research

Over 500 Patients in Clinical Research

The patented Desyncra™ technology was developed in Germany by Professor Peter Tass and his team. Research into CR© Neuromodulation is ongoing at centers throughout the United States and Europe, including:

• Veterans Affairs, Portland, Oregon

• Stanford University, California

• ENT and tinnitus clinics, Germany

• The Tinnitus Clinic, England

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