Medical Laser LLLT CLINICAL RESEARCH AND TREATMENT PROTOCOL

Transcription

1 Medical Laser LLLT CLINICAL RESEARCH AND TREATMENT PROTOCOL ESENLER GROUP

2 TABLE OF CONTENTS TITLE P A G E Alternative Solution In Tinnitus Treatment 1 Study 1. The Role of LLLT in Treatment of Tinnitus - 8 Abstract Introduction Materials and Methods Evaluation Discussion 8 Conclusion 8 Study. Comprehensive therapy of patients suffering from tinnitus Study 3. Comprehensive Laser Rehabilitation Therapy of Tinnitus Abstract Introduction Materials and Methods Therapy: LLLT - Physiotherapy aimed at the initial organ of hearing Placebo LLLT

3 Study 4. Tinnitus and vertigo Study 5. Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction: a feasibility study for chronic tinnitus Study 6. Low-energy laser radiation in the combined treatment of sensorineural hearing loss 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 Literature Treatment Protocol Pre-Examination Evaluation Therapy

4 The Role of LLLT in Treatment of Tinnitus Laser Partner, 6..00, Miroslav Prochazka, M.D., Head doctor of the Jarov Rehab Clinic, Prague Abstract Comprehensive laser rehabilitation therapy of tinnitus has proven successful and beneficial for treatment of this widespread civilization disease. Its long-term results are convincing, bringing significant relief to 36 per cent of patients and even leaving remarkable 6 per cent of patients without any symptoms (see Miroslav Prochazka, Ales Hahn: Comprehensive Laser Rehabilitation Therapy of Tinnitus: Long-Term Double Blind Study on a Group of 00 Patients in 3 Years, Laser Partner No. 51/00). With the results mentioned above we can really speak about a breakthrough. This study brings an additional overview of the role of LLLT (Low Level Laser Therapy) in the treatment. Our results enable us to pinpoint laser as the leading element in the overall therapy of tinnitus. Introduction Tinnitus is an auditory perception appearing without an objective sonic source from the outer environment. 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, fifteen per cent of entire population have experienced at least a tinnitus episode some time, its incidence and severity rising with age up to approx. eighty-five per cent of population older than 60. Our clinic has been treating tinnitus for more than 5 years. We have published three studies on this particular issue, and we are of the opinion that our results are being followed in several countries (Brazil, Cyprus, Sweden, Switzerland, Slovakia, Turkey, Japan, Germany etc.) and implemented in numerous clinics with significant results. Studies published by these clinics show results which are almost identical with our experience. Our last study on a group of 00 patients in the course of three years was finalized in February 00 and published in June 00. 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. This was only possible thanks to our vast experience and long involvement in tinnitus treatments. Materials and methods Our group consisted of 7 patients, 49 males, 3 females, age ranging between 16 to 9 years. The age and sex is given in Table 1

5 Table 1. Distribution of Sex/Age SEX / AGE Male Female TOTAL Diagram 1. Distribution of Sex/Age Male Female 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). Subjective evaluation of suffering 3. Clinical examination (otoneurology, axial skeleton, nystagm, 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. After the therapy audiograms were taken in 6.5 per cent, i. e. 45 patients, showing a slight improvement.

6 Audiogram provides only for numeric range of perception of frequency of sounds, however it does not give us an objective evaluation of quality of hearing. Furthermore, the patients do not see the main improvement in a wider range of frequency of sounds, this 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. Typical audiograms of patients with tinnitus before and after therapy. Laser device with an infrared laser probe (830 nm) and power output 300 mw was used for the study. The following application dosages and frequency modulations were applied on the following points: 1. meatus acusticus externus - in the direction of the axis of the auditory duct - continuous beam 50. processus mastoideus - directed on the center, the vector of the beam in the direction of frequency. We strictly appeal to maintain the direction of the vector of aiming the beam - in fact the target structure of the helix is a shape of several square millimetres. At the beginning, attendance was scheduled to 10 procedures in total, twice a week. Having completed the first series, patients returned after - 3 months for another two series, each consisting of 5-6 therapies, once a week. Evaluation Level of subjective complaints was evaluated according to three scales: 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, 10 etc. per cent, no tinnitus equals 0 per cent. Five-grade scale - analogous to pain scales; Reaching from Gr. I = No tinnitus to Gr. 5 = tinnitus interfering all activities; - Grade I = No tinnitus

7 - 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 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. Less than 50 per cent relief 3. More than 50 per cent relief 4. No more tinnitus, patient free of the disease. This evaluation is identical with our previous study, and it enabled us to compare easily the results of both studies. Table. The Role of LLLT in Tinnitus Treatment: Result Result # Patients Percent No effect 15 %0,8 Less than 50 % relief 19 %6,4 More than 50 % relief %30,6 No more tinnitus 16 %, TOTAL 7 %100,0

8 Diagram. The Role of LLLT in Tinnitus Treatment: Result 15 patients 16 patients 1% % No effect Less than 50% relief patients 31% 19 patients 6% More than 50% relief No more tinnitus 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 , and the initial study aimed at LLLT only. Table 3. Comparative Results Result LLLT only No effect %19,4 %16,0 %0,8 Less than 50 % relief %19,4 %15,0 %6,4 More than 50 % relief %35,5 %43,0 %30,6 No more tinnitus %5,8 %6,0 %,

9 Diagram 3. Comparative Results 50,0% 45,0% 40,0% 43,0% 35,0% 35,5% 30,0% 5,0% 0,0% 15,0% 6,4% 0,8% 19,4% 19,4% 16,0% 15,0% 30,6% 5,8% 6,0%,% LLLT only 10,0% 5,0% 0,0% No effect Less than 50 % relief More than 50 % relief No more tinnitus 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. We have to declare, that we have selected patients during the introductory examination, sorting out patients whose x-ray indicated a possibility of tinnitus caused by vertebral blockades. On the other hand, this selection led to a more pure evaluation of the role of LLLT in the treatment of tinnitus, leaving out both a possible cause and a corresponding treatment. We have been positively surprised that in general the ratio of individual four groups remained similar. The number of patients with no effect of LLLT slightly increased (by 4.8 per cent when compared to the long-term study, by 1.4 per cent in comparison to the original study of 1998). This is obviously caused by the absence of medication and physiotherapy, showing their supportive effect. In the group evaluating improvement as less than 50 per cent the leading role of LLLT can be evidenced best. More than one-fourth of all patients (6.4) report improvement after therapy performed with LLLT only, which is a result better than those in both previous studies (19.4 and 15.0). Impressive results have also been obtained in the last two groups, when we imagine more than one half of all patients reporting significant and/or total relief of tinnitus ( = 5.8 per cent).

10 Conclusion. 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. Comprehensive therapy of patients suffering from tinnitus Prochazka M, Tejnska R. 37 patients suffering from tinnitus (age years) were treated in three ways: 1. Rehabilitation: mobilisation, physical training, physiotherapy.. Same as 1 but with placebo laser added. 3. Same as 1 but with functional laser added. Laser used was 830 nm 300 mw. -3 treatments per week were given, total 10 treatments. Treatment protocol: - - -Tebokan Egb 761 ginko medication was added to treatment. Results were classified as no effect/less than 50% relief/more than 50% relief/no more tinnitus. Table 4. The percent wise outcome for the three groups Result Group 1 Group Group 3 No effect %9.4 %5.8 %19.4 Less than 50 % relief %44.1 %15,0 %19.4 More than 50 % relief %17.6 %5.8 %35.5 No more tinnitus %8.9 %33,4 %5.8 Auris Nasus Larynx. 1997; 4 (1): 39-4

11 Diagram 4. The percent wise outcome for the three groups 50,0% 45,0% 40,0% 35,0% 30,0% 5,0% 0,0% 15,0% 10,0% 5,0% 44,1% 35,5% 33,4% 9,4% 5,8% 5,8% 5,8% 19,4% 19,4% 17,6% 15,0% 8,9% 1.group.group 3.group 0,0% No effect Less than 50 % relief More than 50 % relief No more tinnitus In an extended study over 3 years Prochazka [163] evaluated the effect of laser in a group of 00 patients. These patients were taking gingko biloba preparations (73%) or Betahistadine (39%) and also had physical therapy, mainly directed at the neck vertebrae. The outcome can be examined from Table 5. Table 5. Results of Extended Study Result percent No more tinnitus %6 More than 50 % relief %43 Less than 50 % relief %15 No effect %16

12 Diagram 5. Results of Extended Study 50% 45% 40% 43% 35% 30% 5% 0% 6% 15% 10% 15% 16% 5% 0% No more tinnitus More than 50 % relief Less than 50 % relief No effect addition a group of 31 patients were selected for a double blind study where the same therapy as above was performed, but one group received placebo laser. At 6 months the outcome was as follows; In Table 6. Results of the Double-Blind Study Result With Laser No Laser No more tinnitus %5.8 %0.0 More than 50 % relief %35,5 %5,8 Less than 50 % relief %19.4 %48.4 No effect %19.4 %5,8

13 Diagram 6. Results of the Double-Blind Study 60,0% 50,0% 48,4% 40,0% 30,0% 35,5% 0,0% 10,0% 5,8% 5,8% 5,8% 19,4% 19,4% With Laser No Laser 0,0% No more tinnitus 0,0% More than 50% relief Less than 50% relief No effect Official paper of the Czech Society for the Use of Laser in Medicine Edited under official scientific support of EMLA (European Medical Laser Association) Comprehensive Laser Rehabilitation Therapy of Tinnitus: Long-Term Double Blind Study in a Group of 00 Patients in 3 Years (6.7.00) M. Prochazka, M.D., Rehab Clinic "Jarov", Prague, CZ Ass. prof. A. Hahn, ENT Clinic, FNKV Faculty Hospital, Prague, CZ Abstract Definition of tinnitus records that it is an auditory perception for which there is no objective sonic source from the outer environment. Our original study, published in Laser Partner Clinixperience No. 4/000, has been regarded as a classical tinnitus work. It unambiguously confirmed clinical experience of our predecessors, presented with a high amount of personal enthusiasm (Shiomi, Wilden) but, unfortunately, not much based on statistics. However,

14 recently our study has gained corroboration by originally slightly sceptical medical authorities obtaining statistically almost identical results. Our study has been published more than two years ago. With the time passing by we have been under the impression that the results might be even better than those obtained during several-months therapy in the original cohort of patients. This impression led to a decission that a new comparison with a larger group of patients, than the original forty in our basic study, and followed in a longer time horizon, might be of a certain interest. We were wondering whether our clinical observations, confirmed by personal experience of other clinics, would also find an adequate correlate in statistical expression. A model protocol as well as instruction photographs are attached to the paper. Introduction For our New Study the patients registered in our clinic due to tinnitus for more than three years were chosen. With regard to maximum objectiveness, the patients who had finished attendance due to unknown reasons were included in the "no-effect" group, although we are well aware that a part of them finished the treatment because of various other reasons (such as time cunsuming engagements, problematic transport, family reasons). In a small group of 5 patients we tried to check the objective reasons by a phone query, and indeed, patients gave other reasons whilst 3 patients had finished attendance due to unsatisfactory or no result of procedures. Even though it is interesting for us to have another little group of 6 patients visiting our clinic for check ups and for a series of therapies despite (after a year and more) zero effect of procedures. In a part of this group (in 3 patients) a certain subjective improvement (up to less than 50 per cent relief) can be noticed after a long attendance ( - 3 years). There is certainly a point at issue, to what an extent this subjective improvement can be regarded as an objective one, whether these patients have not settled down to their complaint... It is a problem of little numbers, definitely not having any influence over the total figure, however, from a clinical point of view we consider this observation interesting... It should be also mentioned that, in general, compliance of patients suffering from tinnitus is excellent, which may be caused by the level of their subjective tribulations leading to a craving to get rid of it. Materials and Methods We have evaluated in total 00 patients visiting our clinic since 1997 till now for tinnitus, followed till 001, i.e. at least for 3 years. With our approval 8 patients, who were totally free of tinnitus after a short period of treatment, were crossed off and finished attendance earlier. In this respect we have an odd case history of a female patient, who was relieved of her several years lasting lateralized tinnitus after a single mobilization of distal C vertebra (note that entire 8.8 per cent of patients in our original study were relieved of tinnitus only by mere physiotherapy procedures aimed at axial skeleton - there really exists an often

15 disputed diagnosis of vertebrally conditioned tinnitus). As it can be seen above, patients, who finished the therapy due to reasons unknown, have been incorporated in the group "therapy with no effect". Evaluated group of patients was chosen at random from the whole number of our patients with tinnitus, the main condition being particularly regular attendance during the period of the last three and more years. In all the patients a subjective tinnitus had been diagnosed, i.e. an organic cause of this condition could not be straightly determined by examinations (meaning that especially patients with dg. neurinomus statoacusticus or another organic cause, such as a tumor or a head injury with a positive finding by NMR, CT or EEG, were excluded). In this respect we are well aware that some dubitation could be seen in possible atherosclerotic changes of veins, especially of carotid veins and a. vertebrales, which might also be regarded as an organic cause of tinnitus. However, with almost a hundred-per-cent level of incidence in population of higher age categories it is rather difficult to call these changes a pathology. Table 7. Distribution of Sex and Age among the Patients Age Total Male Female Total Diagram 7. Distribution of Sex and Age among the Patients Male Female AGE

16 Our group (New Group) of patients consisted of 11 males and 88 females (in comparison with our previous study there was an interesting shift towards higher share of males, according to our opinion this more corresponds with the level of distribution of tinnitus within population in relation to work anamnesis and hobbies). Average age was 64 years, ranging within the limits of 15 and 98 years. This meant a shift towards higer categories of age, probably corresponding with the incidence of tinnitus within the population, and maybe also due to the fact that our activities have been covered by media, mainly by those focussed on seniors, and thus new patients could have appeared on the basis of media influence. Level of subjective complaints was evaluated according to, nowadays almost classical, three scales: Percentage Scale (complaints evaluated 100 per cent at the beginning of therapy, according to the level of relief decreased to 80, 70 per cen, possible acceleration of problems goes up to 110, 10 per cent, no tinnitus equals 0 per cent), Five-grade scale - analogous to pain scales (I = no tinnitus, V = tinnitus limiting all activities, II, III and IV = clearly defined complaints) - 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 Graphic scale (patient marking 0 to 10, accompanied by a simple graphics showing face grimaces according to his/her amount of subjective hardship).

17 This combination has proven more than suitable for evaluating such a subjective suffering as tinnitus. Particularly nowadays, when most clinical studies are aimed at evaluation of "quality of life" of individual patients, this combination appears a good criterion to measure such a most valuable state. Above mentioned combination can also make a serious processing possible, with regard to different social, economic, expressive, cultural and intelectual qualities of individual patients. 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 (or even with aggravated condition, however we can say that no patient has reported a setback of tinnitus after the therapy). Less than 50 per cent relief as far as subjective evaluation of the patient is concerned 3. More than 50 per cent relief as far as subjective evaluation of the patient is concerned 4. No more tinnitus, patient free of the disease. This evaluation is identical with our previous study, and it enabled us to compare easily the results of both studies. Therapy LLLT - Physiotherapy aimed at the initial organ of hearing There is no need to discuss necessary parameters of laser probes used. 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 mw probe but a 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: 1. application on meatus acusticus externus - in the direction of the axis of the auditory duct - 5 Hz,

18 . irradiation of processus mastoideus - directed on the center, the vector of the beam in the direction of counterlateral o with 5 Hz pulse frequency. Modulation of 5 Hz we use due to assumed potenciation of stimulative effect of non-invasive laser. We strictly appeal to maintain the direction of the vector of aiming the beam - in fact the target structure of the helix is a shape of several square milimeters. It might be the reason why, when compared with other laser devices with the same output parameters, therapy with CCM probes has proved rather successful due to their characteristic diffusion of the emitted beam, increasing probability of hitting desired target structures (difference of prognostic level of success between hitting the target with a shotgun or with a rifle - thanks to ass. prof. Horak for his witty comparison). LLLT has been applied on 100 per cent of our patients. Attendance was scheduled so that the first series of 8-10 procedures in total, twice a week, be a complex consisting of medication, rehabilitation therapy of axial skeleton, and LLLT. In the interval of - 3 months further courses of therapy follow, usually consisting of 5-6 therapies, once a week, always as a series of LLLT procedures. Therapy of axial skeleton is added when necessary (often not necessary in case of regularly exercising patients, instructed properly in the course of the first series). Medication with Egb 761 continuing in the long term, most of the patients after several months of therapy with a reduced dosage tablets, in the order of at least several more months. A part of the patients in the cycle between procedures has noticed a possibility to titrate medication according to immediate subjective complaints - it means they keep to regular dosage , when tinnitus accelerates switching to , or even to tablets. Possible episodes of accelerated tinnitus usually abate quickly then. In case of long term stabilized patients we plan clinical check ups at least twice a year, always connected with mobilisation of acute blockades of distal C vertebra. Inviting patients for these check ups always in the spring and fall has proved successful. We have noticed one rather substantial phenomenon of LLLT: so far no side effect has been reported. On the other hand, there is an interesting clinical finding in a certain group of patients (6 patients = 3 per cent), an acceleration of tinnitus after the first few LLLT procedures. Positive aspect of this phenomenon is that these patients have always belonged in the group with a massive effect of the therapy (more than 50 per cent relief, or even free of tinnitus at all). This clinical observation has been personally confirmed by other authors working at tinnitus treatment with the use of LLLT (Wilden).

19 Placebo LLLT Due to persistently appearing theories on the effect of LLLT of tinnitus being a mere placebo we have created a minor group of 31 patients in order to confirm or exclude this hypothesis. In the course of three months attendance these patients underwent medication therapy as well as physiotherapy of axial skeleton with classical rehabilitation techniques in the same extent as all the other patients did. Instead of a functional laser source these patients were treated with a probe not emitting laser beam, although there was acoustic as well as visual signalization of operation. Among all other physiotherapeutic devices a non-invasive laser is extremely suitable to perform a placebo test, since its application on a patient is not connected with any subjective feelings nor phenomenons (in contradiction to electrotherapy, for instance). As we work with an IR wavelength, it was possible to arrange a double blind study, for the fact whether the therapist works with a device emitting laser beam or with a placebo unit was not even known to the therapeutic personnel. The results -unambiguously confirming that there is no placebo involved in LLLT- are summarized in Table 8. The outcome is undoubtedly statistically significant. Table 8. Results of Placebo Test Effect of Therapy Original Group (31 patients-6 months) New Group (00 patients-3 years) Placebo Group (31 patients-3 months) No effect 19.4 % 16.0 % 5.8 % Less than 50 per cent relief 19.4 % 15.0 % 48.4 % More than 50 per cent relief 35.5 % 43.0 % 5.8 % No more tinnitus 5.8 % 6.0 % 0.0 %

20 Diagram 8. Results of Placebo Test 60,0% 50,0% 48,4% 40,0% 43,0% 30,0% 35,5% Original Group (31 patients-6 months) 0,0% 10,0% 19,4% 19,4% 16,0% 5,8% 15,0% 5,8% 5,8% 6,0% New Group (00 patients-3 years) Placebo Group (31 patients-3 months) 0,0% No effect Less than 50% relief More than 50% relief No more tinnitus 0,0% Tinnitus and vertigo Jan Tunér, DDS Laser-Medical Society Grängesberg, Sweden A new and promising indication for laser therapy is tinnitus. 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 ginko 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 since it does not appear to be a dental indication. 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 low level laser therapy is an appropriate treatment modality for the yet undefined subgroup

21 of tinnitus/vertigo patients with a CMD background. Laser therapy will reduce pain levels, ease muscular spasms and revert the vicious circle. Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction: a feasibility study for chronic tinnitus Tauber S, Schorn K, Beyer W, Baumgartner R., Department of Otolaryngology, Ludwig- Maximilians- University of Munich 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 sensorineural hearing loss. 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. This feasibility study first presents a laser application system enabling dose-controlled transmeatal cochlear laser-irradiation (TCL), as well as preliminary clinical results in patients with chronic cochlear tinnitus. The novel laser TCL-system, consisting of four diode lasers (lambda=635 nm-830 nm) and a new specific head-set applicator, was developed on the basis of dosimetric data from a former light-dosimetric study. In a preliminary clinical study, the TCL-system was applied to 35 patients with chronic tinnitus and sensorineural hearing loss. The chronic symptoms persisted after standard therapeutic procedures for at least six months, while retrocochlear or middleear pathologies have been ruled out. The patients were randomised and received five single diode laser treatments (lambda=635 nm, 7.8 mw cw, n=17 and lambda=830 nm, 0 mw cw, n=18) with a space irradiation o 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. The first clinical use of the TCLsystem has been well tolerated without side-effects and produced no observable damage to the external, middle or inner ear. Changes of tinnitus loudness and tinnitus matching have been described. After a follow-up period of six months tinnitus loudness was attenuated in 13 of 35 irradiated patients, while two of 35 patients reported their tinnitus as totally absent. Hearing threshold levels and middle ear function remained unchanged. Further investigations by large double-blind placebo controlled studies are mandatory for clinical evaluation of the presented TCL-system and its therapeutic effectiveness in acute and chronic cochlear dysfunction.

22 Low-energy laser radiation in the combined treatment of sensorineural hearing loss and Meniere's disease Pal'chun VT, Lapchenko AS, Kadymova MI, Kucherov AG. 59 patients with neurosensory hypoacusis and 45 with Meniere's disease underwent heliumneon laser intra- or supravascular radiation of blood. The treatment proved effective in acute neurosensory hypoacusis and Meniere's disease. Light dosimetry and preliminary clinical results for low level laser therapy in cochlear dysfunction Beyer W et al. The light distribution inside the cochlear windings produced by irradiation of the tympanic membrane was quantitatively measured ex vivo for wavelengths of 593, 61, 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. 5 irradiations within weeks each with a space irradiation of 4 cochlear position to be treated. Diode lasers of 635 or 830 nm, 15 patients each, were used. 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. Infrared laser applied into the meatus acousticus Dr. Shiomi [686] has investigated the effect of infrared laser applied directly into the meatus acousticus, 1 J, once a week for 10 weeks. The result of this non-controlled study is as follows: 6% 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.

23 Ex-vivo laser penetration study Dr. Tauber [1091] has performed an ex-vivo laser penetration study. Based on these cochlea itself. Irradiation via the mastoid showed values 103 to 105 times smaller (depending on wavelength) than irradiation through the tympanic membrane. 30 patients were treated five times within 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. Average duration of tinnitus of 10 years Dr. Hahn [1310] examined 10 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 was audiometrically confirmed in 50.8% of the patients; 10 db in 18, 0 db in, 30 db in 10, 40 db in 6 and 50 db in 5 patients. Table 9. Result of the Research Decrease in Tinnitus 10 db 0 db 30 db 40 db 50 db # Patients

24 Table 10. Literature Innenohrstörungen Hearing loss and tinnitus Irradiation on tinnitus Irradiation on inner ear Tinnitus Therapy Tinnitus Neurootoligische Erkrankungen Chronic tinnitus Treatment of tinnitus Cochlear dysfunction Laser irradiation of the cochlea Der Körper des Menschen Indication Author Name of Publication Date Title U. Witt C. Felix P. Plath J. Oliver Y. Shiomi H. Takahashi I. Honjo Y. Shiomi A. Hahn I. Sejna k. Stoblova M. Prochazka R. Tejnska R. Swoboda A. Schott H. Wedel L. Calero M. Walger F. Mirz R. Zachariae S. Andersen W. Beyer S. Tauber R. Baumgartner K. Schorn Adolf Faller Selective photobiochemotherapy in the combination of laser and gingkoplan extracts Adv. Otorhinolaryngol. 1995; 49:101-4 Auris Nasus Larynx 1997;4(1):39-4 Pract Otol (Kyoto) 1994; 87: Acta Otolaryngol 001, 545, 9-93 Proc. Laser Florence 99 Treatment of neurotologic diseases with Gingko biloba and low level laser therapy Soft-laser/Gingko therapy in chronic Tinnitus. Adv Otorhinolaryngol. 1995;49:105-8 The low-power laser in the treatment of tinnitus. Clin Otolaryngol 1999; 4: Selektive photo-biochemotherapie in der Kombination Laser und Ginko- Pflanzenektrakt nach der Methode Witt (unpublished material) Results of combined low-power laser therapy and extracts of Ginko biloba in cases of sensorineural hearing loss and tinnitus Efficacy of transmeatal low power laser irradiation on tinnitus (a preliminary repo Effect of low power laser irradiation on in ear (in Japanese) 001 Combined Laser-Egb 761 Tinnitus Therap Light dosimetry and preliminary clinical results for low level laser 1999 therapy in cochlear disfunction. Proc. Laser Florence 99 Experimental study for laser irradiation of the cochlea. Lasers 001 Surg Med 001;8:(1):18-6 Der Körper des Menschen, Thieme Verlag 1995 Comprehensive therapy of patients suffe from Tinnitus Behandlung neurootologischer Erkrankungen mit Ginko biloba Hevert, Hyperforat und low-power-laser-therapy (Medizinische Akademie Erfurt) Soft-laser/Gingko therapy in chronic Tinnitus (a placebo controlled study) The low-power laser in the treatment of tinnitus Light dosimetry and preliminary clinical results for low level laser therapy in cochlear disfunction Lightdosimetric quantitative analysis of t human petrous bone 1995 Der Körper des Menschen Low Level Laser Application H. Walter A. Walter Photobiological Basics of Low Level Laser Application. Dt. Z. für Akupunktur / Low Level Laser Application Low-Power Laser Therapy T. Karu Photobiology of Low-Power Laser Therapy, Harwood Academic Publishers, New York Photobiology of Low-Power Laser Therap Tinnitus Olivier J. Plath P. Laser Therapy, 5: , 1993, John Wiley & Sons, Ltd Combined low power laser therapy and extracts of Ginkgo

25 TREATMENT PROTOCOL PRE-EXAMINATION EVALUATION Co-operation between specialists neurology ear-nose-throat rehabilitation (or physiotherapy) Acoustic trauma in the anamnesis (regardless to one-time episode or a chronic burden) Gathering anamnesic data Abuse of potentially ototoxic medicaments (especially antibiotics, total anesthesia) Ocurrence of tinnitus in family anamnesis Thorough otoneurological examination Clinical examination Thorough examination of axial skeleton Nystagmus Blood pressure Audiogram + masking of tinnitus CT/NMR Technical means of examination X-ray of C vertebra ENG Tinnitogram Lab tests Functional pathology of axial skeleton Especially detection of diabetes mellitus Lipid metabolism disorders Patients should always be examined by a specialist on myoskeletal medicine

26 THERAPY Preferably indicated by an ENT specialist: vasoactive medication, antihistaminics, nootropics Medication Good experience with Gingko biloba preparations: Egb 761, Tanakan, Tebokan pills Frequent changing of the scheme of medication not suitable Aimed at the axial skeleton 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)]. Rehab therapy Traction therapy horizontal tractions, preferrably devices with pulsed modulation Mobilization (manipulation) of current functional blockades. Therapeutic physical exercise, techniques aimed at distal parts of neck vertebra, postizometric relaxation activities, automobilization activities Basic requirements on the device: IR (830nm), power output 50 mw mw Probe adjustable for the application to ear canal Quantum Laser Therapy Irradiation points: procesus mastoideus aiming in the direction of contra-lateral orbit meatus acusticus externus in the direction of the acoustic duct. Mastoideus: pulsed 5 Hz. Duct: 50 J continuous, followed by 5 J, 5 Hz. 3 sessions for the first week, 1 session per week for the following 9 weeks. Following the first 1 sessions, after 6 months, 1 session per week for weeks. 1+ sessions in total