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Tinnitus management green laser Pen cold laser Pen soft laser Pen

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1 Tinnitus management green laser Pen cold laser Pen soft laser Pen
MEDICAL CITY 3-4/10/2012

2 Studies In Tinnitus Treatment
Study 1. The Role of LLLT (low level laser therapy) in Treatment of Tinnitus Study 2. Comprehensive therapy of patients suffering from tinnitus. Study 3. Comprehensive Laser Rehabilitation Therapy of Tinnitus . Study 4. Tinnitus and vertigo. Study 5. Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction: a feasibility study for chronic tinnitus 4/6/2017

3 Study 8. Infrared laser applied into the meatus acousticus
Study 6. Low-energy laser radiation in the combined treatment of SNHL and Meniere's disease Study 7. Light dosimetry and preliminary clinical results for low level laser therapy in cochlear dysfunction Study 8. Infrared laser applied into the meatus acousticus Study 9. Ex-vivo laser penetration study Study 10. Average duration of tinnitus of 10 years 4/6/2017

4 Tinnitus pen Study 1. The Role of LLLT in Treatment of Tinnitus
(Low Level Laser Therapy) used in the treatment of tinnitus, is a Comprehensive laser rehabilitation therapy of tinnitus which has proven successful and beneficial for treatment of this widespread civilization disease. Its long-term results are convincing, bringing significant relief to 36 % of patients and even leaving remarkable 26 % of patients without any symptoms, in both gp = 62%.. the results of study enable us to pinpoint laser as the leading element in the overall therapy of tinnitus. 4/6/2017

5 Definition:- Tinnitus is an auditory perception appearing without an objective ext environmental source. Tinnitus can be subjective (heard only by the patient) and objective (sound can be even heard also by others). Our study, however, deals with patients suffering from subjective tinnitus only. According to literature,50% of entire population have experienced at least a tinnitus episode some time,(10-15% of the population reports experiencing tinnitus with regularity Beltone study) its incidence and severity rising with age up to approx. 85% of population older than 60 year 4/6/2017

6 Since there have always been efforts to evaluate an exact role of LLLT in treatment of tinnitus, apart from medication and physiotherapeutic manipulation of neck vertebra as an integral part of the comprehensive therapy, we have decided to create a separate group of patients to be treated only with laser. 4/6/2017

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8 Materials and methods Our group consisted of 72 patients, 49 males, 23 females, age ranging between 16 to 92 years. The age and sex is given in the Table Conclusion :- 1- male more than females 2- tinnitus increased with age. 3- tinnitus is increased after 40 y age. 4/6/2017

9 2. Subjective evaluation of suffering.
Prior to the application of LLLT, all the patients underwent the following pre-therapy examination: 1. Anamnesis (aimed especially at the fact whether tinnitus was caused by an acoustic trauma, as well as at genetic predisposition). 2. Subjective evaluation of suffering. 3. Clinical examination (otoneurology, axial skeleton, nystagmus, blood pressure). 4. Technical examination (audiogram, x-ray of neck vertebra, ENG, tinnitometry). 5. Laboratory testing Audiograms were taken in all the patients prior to the therapy. 4/6/2017

10 Hearing threshold remains usually on a similar level, but the main benefit is the absence of the additional burdening sound caused by tinnitus. Therefore the patients can better analyze sounds in general, their hearing is “refreshed” as they usually describe the result of the therapy. 4/6/2017

11 Evaluation of the patients in pre & post treatment:-
Level of subjective complaints was evaluated according to three scales: 1- Percentage scale %- complaints evaluated 100 per cent at the beginning of therapy (Blue), according to the level of relief decreased (Green) to 80, 70 etc. per cent, possible acceleration of problems (Red) goes up to 110, 120 etc. per cent, no tinnitus equals 0 per cent. 2- Five-grade scale - analogous to pain scales; Reaching from Gr. I = No tinnitus to Gr. 5 = tinnitus interfering all activities; - Grade I = No tinnitus - Grade II = No interfering sound perceived during the day, only in evenings, causing no discomfort - Grade III = Interfering sound perceived during the day, interrupting drowse only - Grade IV = Interrupting drowse and sleep, interfering sound causing discomfort during the day - Grade V = Unbearable discomfort, interfering all activities 4/6/2017

12 3- Graphic scale - Patient marking 0 to 10, accompanied by a simple graphics showing face grimaces according to his/her amount of subjective hardship. In order to simplify the effect of therapy as much as possible the results were divided in four groups: 1-Patients with no effect of comprehensive therapy 2-Less than 50 per cent relief 3-More than 50 per cent relief 4-No more tinnitus, patient free of the disease. 4/6/2017

13 Evaluation of the patients in pre & post treatment:-
Level of subjective complaints was evaluated according to three scales: 4/6/2017

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16 The Role of LLLT in Tinnitus Treatment:
26% less than 50% 31% more than 50% 22% no more tinnitus Total 79% has effect 4/6/2017

17 It was interesting to compare our latest results (LLLT only) with those of our previous studies, i. e. our study made in 1998, long-term study between 4/6/2017

18 Discussion Hippocratic Oath orders us to treat patients to the best of our knowledge and ability.
Since our longterm experience in comprehensive treatment of tinnitus has been based on the triad of physiotherapeutic manipulation, medication, and LLLT, we were at a loss whether we would not harm our patients in a way, giving them only a part of the treatment, mere LLLT. All possible treatment should be given to the patients ( laser, physiotherapy, medications, HA, acupuncture, psychological support) 4/6/2017

19 Conclusion 22.2 per cent patients suffering from tinnitus never more after treatment with therapeutic laser is a great success of LLLT. It only confirms the leading role of LLLT within comprehensive laser rehabilitation therapy of tinnitus. On the other hand we must stress the necessity to apply the two remaining parts of our therapeutic triad as well, since medication and physiotherapeutic manipulation are integral parts of the general care of our patients, and we should not deprive the suffering of the means and methods capable of bringing them more relief, which we are aware of. 4/6/2017

20 Study 2. Comprehensive therapy of patients suffering from tinnitus (laser + physio + medications)
In an extended study over 3 years Prochazka [1263] evaluated the effect of laser in a group of 200 patients. These patients were taking gingko biloba preparations (73%) or Betahistadine (39%) and also had physical therapy, mainly directed at the neck vertebrae. Laser therapy was performed with a 300 mW GaAlAs laser, 75 J/cm² into the ear and 135 Joul/cm² behind the ear. 4/6/2017

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22 In our clinic we use the following techniques of LLLT application on:
. We need an infrared laser beam with a sufficient power output (we have been using an IR 300 mW laser probe, we also tried using a 450 mili Watt probe but part of our patients reported a subjectively unpleasant thermic effect in the area of application). On the other hand, we pay maximum attention to irradiation of a sufficient dosage of energy. In our clinic we use the following techniques of LLLT application on: 1. EAM- in the direction of the axis of the auditory duct - continuous beam 50 J/cm² followed by 25 J/cm², frequency modulation of 5 Hz, 2. Mastoid processus - directed on the center, the vector of the beam in the direction of counterlateral orbit, continuous beam 90 J/cm² , followed by 45 J/cm² with 5 Hz pulse frequency. 4/6/2017

23 Study 4. Tinnitus and vertigo + CMD
This inner ear disease is a growing problem in noisy modern society and the number of persons suffering from tinnitus is increasing. Traditional treatment for tinnitus is psychological support or various masking procedures. Acupuncture and ging-ko extracts have been tried with limited success. Laser therapy alone offers a new and promising treatment modality. The correlation between tinnitus/vertigo and cranomandibular disorders (CMD) has been known for quite some time, yet few dentists seem to be aware of this. It is not natural for the dentist to ask, nor for the patient to inform the dentist about such a situation. 4/6/2017

24 However, quite a number of tinnitus/vertigo patients will be relieved of their symptoms if a proper CMD treatment is performed. Low level lasers have been used to treat tinnitus patients with reasonable success, if sufficient energy and suitable treatment technique is used. These lasers have also proved themselves successful in the treatment of CMD. It is obvious, therefore, that LLLT is an appropriate treatment modality for the yet undefined subgroup of tinnitus/vertigo patients with a CMD background. Laser therapy will reduce pain levels, ease muscular spasms and revert the vicious circle. 4/6/2017

25 Study 5. Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction (tinnitus loudness)
a feasibility study (دراسة عملية) for chronic tinnitus. Low-level-laser-therapy (LLLT) targeting the inner ear has been discussed as a therapeutic procedure for cochlear dysfunction such as chronic cochlear tinnitus or SNHL. Former studies demonstrate dose-dependent biological and physiological effects of LLLT such as enhanced recovery of peripheral nerve injuries, which could be of therapeutic interest in cochlear dysfunction. To date, in patients with chronic tinnitus mastoidal and transmeatal irradiation has been performed without systematic dosimetric assessment. However, light-dosimetric studies on human temporal bones demonstrated that controlled application of laser light to the human cochlea depends on defined radiator position within the external auditory meatus. 4/6/2017

26 The novel (رواية) laser TCL-system :-
The chronic symptoms persisted after standard therapeutic procedures for at least six months, while retrocochlear or middle ear pathologies have been ruled out .For evaluation of laser-induced effects complete otolaryngologic examinations with audiometry, tinnitus masking and matching, and a tinnitus- self-assessment were performed before, during and after the laser-irradiation. 1- Changes of tinnitus loudness and tinnitus matching have been described. 2- After a follow-up period of six months tinnitus loudness was attenuated in 13 of 35 irradiated patients, while 2 of 35 patients reported their tinnitus as totally absent. 3- Hearing threshold levels and middle ear function remained unchanged. 4/6/2017

27 helium-neon laser intra- or supravascular radiation of blood.
Study 6. Low-energy laser radiation in the combined treatment of SNHL and Meniere's disease 59 patients with neurosensory hypoacusis and 45 with Meniere's disease underwent helium-neon laser intra- or supravascular radiation of blood. The treatment proved effective in acute neurosensory hypoacusis and Meniere's disease. 4/6/2017

28 Study 7. Light dosimetry and preliminary clinical results for low level laser therapy in cochlear dysfunction The light distribution inside the cochlear windings produced by irradiation of the tympanic membrane was quantitatively measured ex vivo for wavelengths of 593, 612, 635, 690, 780 and 805 nm by means of video dosimetry. The transmission of light across the tympanic cavity and the promontory depends strongly on the wavelength. Spatial intensity variations of a factor of 10 and more inside the cochlear windings have been measured. The clinical study was performed with 30 patients suffering from chronic permanent tinnitus During and after irradiation there was no significant change of hearing. However, 40% of the patients reported a slight to significant attenuation of the tinnitus loudness of the treated ear. There was no difference between the two wavelength groups. 1- irradiation of cochlea 2- TM as radiator 3- diff wave length used. 4- intensity measured inside cochlea using dosimeter 5- results 40% of patients reported a slight to significant significant attenuation of the tinnitus loudness of the treated ear. 6-There was no difference between the two wavelength groups 4/6/2017

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30 Study 8. Infrared laser applied into the meatus acousticus
(IR EAM) Dr. Shiomi [686] has investigated the effect of infrared laser applied directly into the meatus acousticus, 21 J, once a week for 10 weeks. The result of this non-controlled study is as follows: 26% of the patients reported improved duration, 58% reduced loudness and 55% reported a general reduction in annoyance. The same author [687] has also examined the effect of light on the cochlea using guinea pigs. Direct laser irradiation was administered to the cochlea through the ( round window). The amplitude of CAP was reduced to 53-83% immediately after the onset of irradiation. The amplitude then returned to the original level. The results of this investigation suggest that laser therapy might lessen tinnitus by suppressing the abnormal excitation of the eighth nerve of the organ of Corti. 4/6/2017

31 Study 8 1- Infrared laser applied into the meatus acousticus (IR EAM), once a week for 10 weeks. 2- The result of this non-controlled study is as follows A -26% of the patients reported improved duration, B- 58% reduced loudness and C- 55% reported a general reduction in annoyance. The same author [687] has also examined the effect of light on the cochlea using guinea pigs. Direct laser irradiation was administered to the cochlea through the round window. The amplitude of CAP was reduced to 53-83% immediately after the onset of irradiation. The amplitude then returned to the original level. The results of this investigation suggest that laser therapy might lessen tinnitus by suppressing the abnormal excitation of the eighth nerve of the organ of Corti. 4/6/2017

32 Study 9. Ex-vivo laser penetration study (mastoid rout)
Ex-vivo laser penetration study Dr. Tauber [1091] has performed an ex-vivo laser penetration study. Based on these findings it was possible to calculate the energy needed to obtain a dose of 4 J/cm? in the cochlea itself. Irradiation via the mastoid showed values 103 to 105 x times smaller (depending on wavelength) than irradiation through the tympanic membrane. 30 patients were treated five times within 2 weeks. One group was irradiated with 635 nm diode laser, the other with 830 nm diode laser. By self-assessment around 40% of the patients reported a slight to significant attenuation of the tinnitus loudness of the irradiated ear. Conclusion : EAM rout better than Mastoid rout 4/6/2017

33 Study 10. Average duration of tinnitus of 10 years
Dr. Hahn [1310] examined 120 patients with an average duration of tinnitus of 10 years. The patients underwent puretone audiometry, speech audiometry and objective audiometry tests. The intensity and frequency of tinnitus was also determined. EGb 761 was administered 3 weeks before the start of laser therapy. The patients underwent 10 sessions of laser therapy, each lasting 10 minutes. An improvement in tinnitus loudness was audiometrically confirmed in 50.8% of the patients; 10 dB in 18, 20 dB in 22, 30 dB in 10, 40 dB in 6 and 50 dB in 5 patients. 4/6/2017

34 Table 9. Result of the Research Decrease in Tinnitus 10 dB 20 dB 30 dB
10 session ,10 min each 120 patients 10 ys Table 9. Result of the Research Decrease in Tinnitus 10 dB 20 dB 30 dB 40 dB 50 dB Patients # 18 22 10 6 5 4/6/2017

35 TREATMENT PROTOCOL PRE-EXAMINATION EVALUATION
Co-operation between specialists -neurology -E.N.T -rehabilitation (or physiotherapy) Gathering anamnesic data Acoustic trauma in the anamnesis - past hx - (regardless to one-time episode or a chronic burden) Abuse of potentially ototoxic medicaments (especially antibiotics, total anesthesia) Ocurrence of tinnitus in family anamnesis Clinical examination Thorough otoneurological examination Thorough examination of axial skeleton Nystagmus Blood pressure 4/6/2017

36 Technical means of examination Audiogram + masking of tinnitus
CT/NMR (nuclear MR) X-ray of cervical vertebra ENG vest syst Tinnitogram Lab tests Especially detection of diabetes mellitus Lipid metabolism disorders Functional pathology of axial skeleton Patients should always be examined by a specialist on myoskeletal medicine All test has been done to exclude central path tumors….. 4/6/2017

37 Frequent changing of the scheme of medication not suitable
a- Preferably indicated by an ENT specialist: vasoactive medication, antihistaminics, nootropics b- Good experience with Gingko biloba preparations: Egb 761, Tanakan, Tebokan pills Frequent changing of the scheme of medication not suitable 2- Rehab therapy Aimed at the axial skeleton a- Physiotherapy focussed on analgesia and relaxation of muscle spasms [DD currents by Bernard, interferential currents, pulsed magnetic field (these techniques applied on distal parts of neck vertebra)]. b-Traction therapy – horizontal tractions, preferrably devices with pulsed modulation c- Mobilization (manipulation) of current functional blockades. 4/6/2017

38 Probe adjustable for the application to ear canal
Basic requirements on the device:IR (830nm), power output 250 mW mW Probe adjustable for the application to ear canal Irradiation points: -procesus mastoideus aiming in the direction of contra-lateral orbit - meatus acusticus externus in the direction of the acoustic duct. -Mastoideus: 90 J/cm?–cw,followed by 45 J/cm? –pulsed 5 Hz. - Duct: 50 J continuous, followed by 25 J, 5 Hz. 4/6/2017

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42 During the irradiation
1- smoke 2- alcohol. 3- salt. 4- red meat +fat+ spice 5- dried fruits. 6- coffee 7- chocolate, caramel, candies, sorbes 8- coke, soda pop,… 9- loud music…. Use earplugs. 10- stress. 11- not tired yourself. The same requirements that of ENG , it mean alert vest + aud syst 4/6/2017

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49 SOFT LASER PEN FOR TINNITUS TREATMENT
Technical Features TINNITUS PEN Green Medical Laser (LLLT) Wave Length: 650mm Power: < 5mw Battery Type: 2 x 1.5 v “AAA” Alkaline Working Temperature: C Dimensions: 152 (l)x 13 (dia) mm Weight: 65gr Beam Mode: Constant Working Mode: cw Factor: M2<1.2 Beam Diameter(1/e2): <1.5mm Divergence: <1.2 mrad 4/6/2017

50 INTRODUCTION Laser consists of the first letters of “Light Amplification by Stimulated Emission of Radiation”. Lasers only diffuse soft energy. Lasers have been used in medical and cosmetic sectors for more than 30 years. The benefits of Laser technologies are improving continuously. Tinnitus Pen Soft Laser is the latest laser technology of our day. Treatment is totally safe and painless. It has been proven that the laser beams get into the bottom layers of the skin and works as a treatment bio-simulation system on the metabolism. Several diseases arise because of the lack of ATPs which are the source of life for cells. ATP is a key element for our cells. ATP provides the necessary energy for Mitochondria that are being in process through the glucose burning process. Lack of ATP may cause damage in the cells, but powerful Tinnitus Pen Soft Laser light (650mm wave length) imitates the glucose burning process. Therefore, Tinnitus Pen Soft Laser may help the damaged cells to renew themselves. 4/6/2017

51 How laser work? A laser beam is made of photons, which are absorbed by cells that are not functioning well , the photon speedup the production of healthy new cells by increasing the action of ATPs(adenosphine triphosphate) a molecule that carries energy in the cells take in nutrients faster & get ride of waste product sooner, laser increase blood flow to applied area. 4/6/2017

52 COMPARISION:- Lasers applied by professionals are more powerful than the laser power of the Tinnitus Pen Soft Laser. There is no need for professionals to apply the Tinnitus Pen Soft Laser. Since Tinnitus Pen Soft Laser has less beam power, it can be applied by unprofessional people without any risks. Tinnitus Pen Soft Laser should not be compared with the beam of laser pointers 4/6/2017

53 Laser Acupuncture Method:-
APPLICATION METHOD:- There is no danger for overdose application of Tinnitus Pen Soft Laser. Although it is applied more to a specific area, it has no side effects because our cells have the ability to reflect any surplus soft radiation. Tinnitus Pen Soft Laser may help people to regain their health rapidly by changing and balancing their body chemistry. However, desired effect may not be observed or may be limited. Principally there are 3 different application methods; Area Method:- Area method leaves 1 cm of space between the skin and the tip of the laser. There is no contact with the skin. Most importantly, if there is an open wound this method should be applied. Contact Method:- The skin contacts the tip of the laser. If there is no open wound on the application area this method can be applied easily. This method is more effective and efficient. Please do not forget to decontaminate the tip of the laser if the patient has any contagious disease. Laser Acupuncture Method:- Laser beam leads to a bio-simulation just like the acupuncture needles. Compared to acupuncture needles, Tinnitus Pen Soft Laser can be considered as totally painless and risk-free of contagious disease diffusion way of acupuncture needles. 4/6/2017

54 AFTER APPLICATION (UYGULAMA SONRASI)
BEFORE APPLICATION:- Application area should be washed and cleaned by an alcohol-free soap. Skin should be dried carefully before application. AFTER APPLICATION (UYGULAMA SONRASI) It would be beneficial to use a humidifying cream on the application area after the application. 4/6/2017

55 Just before the ear entrance through the ear canal.
Application Time:- It should be applied to the ringing ear side for 20 minutes. If both ears are ringing than it should be applied 20 minutes for each side. Just before the ear entrance through the ear canal. Apply it to the mastoid bone placed behind your ear. Apply it for 10 minutes to A and B points. Application Period:- It should be applied once a day for 90 days of application period. For long term chronic tinnitus it can be applied twice a day. Once in the morning and once in the evening. People having insomnia (sleeping problems) should not perform treatment on evenings. Application should be done on the same time every day. 4/6/2017

56 -Be sure that your ears are clean before application.
Considerations :- -Be sure that your ears are clean before application. -Lie on a comfortable area. -Be sure that there is no noise around. If you don’t have the chance to move to a quite place, just do not consider the noises and continue the application. -Be calmer and avoid stress. -Sleep enough and long at nights. -Avoid noise in your daily life. -You can get help to sleep.(Sleeping pills, therapy or tinnitus masker) Conclusion:- Laser beams gets into deeper layers of the skin and acts like the therapeutic bio-simulator effecting the blood circulation. Since laser beams are directly related to metabolism, there is absolutely no risk to worsen the ringing. However, people may realize some changes during the first weeks of application. This is generally a positive response of the metabolism to the laser application and it is a sign of healing process. People having chronic tinnitus, psychological therapy would be beneficial with the application of the Tinnitus Pen Soft Laser. More than one period can be applied to patients having chronic tinnitus. 4/6/2017


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