PHOTOBIOSTIMULATING LASER LIGHT - SCIENTIFIC EVIDENCE Photobiostimulative treatment studies in LASER medicine have been conducted since 1961.

There are approximately 3,000 studies concerning the positive biostimulative effects of LASER light. There are more than a dozen studies supporting the positive treatment effects on tinnitus and there are dozens of studies supporting positive effects on hearing and balance disorders. Al Kolayliogly, ent specialist from Turkey, was in May 2001 visiting Michael Zazzio at the Audio Laser-Kliniken, Lutz Wilden in BadFssing and Miroslav Prochzka in Prague. Al has ever since been treating inner ear disorders with LASER therapy. During year 2006 Al Kolaylioglu contacted the ent research institutions in Turkey and asked them to conduct a tinnitus treatment study using LASER therapy. The doctors Gungor, Dogru, Cincik, Erkul and Poyrazoglu at the Hydarpasa Military Hospital conducted a positive Gold Standard study. A. GUNGOR, S. DOGRU, H. CINCIK, E. ERKUL, F. POYRAZOGLU POSITIVE GOLD STANDARD LASER THERAPY STUDY ON TINNITUS TREATMENT PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, CONTROLLED TINNITUS STUDY At the department of otorhinolaryngologi at the Haydarpasa Military Hospital in Turkey the researchers used a 650 nm LASER. The LASER light was administrated daily for a week. The patients evaluated their tinnitus symptoms on a 5 point scale. The study included 66 ears on 45 patients on patients suffering from chronic unilateral or bilateral tinnitus. Evaluation was made before and two weeks after finished therapy. The improvements were in the functional LASER group as follows: 48.8 % had less loudness, 57.5 % had less duration, 55.5 % had a lower degree of annoyance. No significant improvement was obtained in the placebo group. The research team concludes that the LASER method is useful for the treatment of chronic tinnitus.

D. CUDA & A. De CARIA POSITIVE GOLD STANDARD LASER THERAPY STUDY ON TINNITUS TREATMENT PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, CONTROLLED TINNITUS STUDY At the department of otorhinolaryngologi and tinnitus at the Guglielmo da Saliceto hospital in Piacenza in Italy the doctors and researchers used a similar 650 nm LASER for the treatment of tinnitus as used in the study conducted by Gungor et al in Turkey year 2007. In Cuda's and De Caria's study LASER therapy was combined with counseling according to the TRT method. The treatment at the hospital in Piacenza went on for three months and 61.5 % of the patients in the functional LASER group got an improvement of their tinnitus. In the same LASER group 3.8 % experienced a worsened tinnitus. The patients in the study had at least for three months been suffering from chronic continuous tinnitus related to cochlear pathology. Patients with psychiatric diseases were excluded and so were patients who were on medications that could be suspected to cause the tinnitus symptoms. The study was prospective, controlled, randomized and double blind. The control group consisted of patients receiving counseling according to the TRT model and placebo LASER (non functional LASER). In the placebo group 35 % had improvements on their tinnitus symptoms while 20 % experienced a worsened tinnitus. The difference between the groups

is significant, p<0.01. M. ZAZZIO - ADMINISTRATING LASER LIGHT TO THE INNER EAR In November 2006 Michael Zazzio at the Audio Laser-Kliniken in Sweden irradiated a pig's ear from the outside after dividing the skull of the pig. The tissue sample measured 36 millimeters from the tympanic membrane to the inner incision of the skull. The LASER light passing through the tissue was photo documented. Through the results of the study, it is beyond doubt that LASER light in inner ear therapy gets into the inner ear cochlea through the ear canal, via the tympanic membrane, passing the hearing bones and getting through the shell of the cochlea if the LASER probe is placed correctly and in an optimal position, and if the LASER light is administrated in the right direction. The LASER used in the scientific LASER light penetration study conducted by Michael Zazzio on the 11th of November 2006 was a collimated 35 mW InGaAlP LASER of 650 nm wavelength. LASER light with a wavelength of just above 800 nm has better penetration ability in tissue than the 650 nm LASER, but the 800 nm LASER light is not as visible to the human eye as shorter wavelengths.

Picture 1.

Photo: Michael Zazzio

Picture 2.

Photo: Michael Zazzio

Picture 3.

Photo: Michael Zazzio

This picture displays how the LASER light irradiates the ear canal from the outside of the skull bone. The LASER light is aimed towards the inner ear, which is situated a couple of centimeters inside the tissue sample. The black wedge-shaped object in the picture is the LASER probe.

This picture displays the same tissue sample, but here it is taken from the inside of the skull bone, which has been divided halfway into the brain but still contains the hearing organ. The red area in the picture is LASER light irradiating the part where the cochlea of the inner ear is found.

This close-up photography is taken from the same position as picture 2. This enlarged photo clearly displays that the red light ball inside the tissue is LASER drowning the tissue in red LASER light. In this sample it is the tissue in the area where the hearing organ (the cochlea) is found.

J. OLIVER & P. PLATH - RESEARCH ABOUT TINNITUS TREATMENT A single blind study was conducted in 1991-1992 and published in 1993 by J. Oliver and Prof. P. Plath. The study showed that LASER therapy in combination with Ginkgo Biloba can have a positive effect on tinnitus symptoms. The study is one of several studies with positive effects using LASER. Ginkgo Biloba (EGb 761) was given to 40 patients, 20 in the LASER treated group and 20 in a placebo LASER group. After therapy 50% of the patients in the LASER group had their tinnitus

diminished while only 5% among those in the control group had any relief. The study was published in the medical journal Laser Therapy, 1993, no 5, pages 137-139. RESULT AFTER TREATMENT OF TINNITUS SYMPTOMS Decreased >= 10 dB Decreased >= 20 dB Free from symptoms GROUP 1 Ginkgo Biloba + Placebo-LASER 5% 0% 0% GROUP 2 Ginkgo Biloba + LASER 50 % 30 % 10 %

The table above displays the results from the study by Oliver & Plath. M. PROCHZKA & R. TEJNSKA - RESEARCH ABOUT TINNITUS TREATMENT Another controlled, randomized, double blind study with even better results was a study conducted in 1999 and presented the same year at the Florence LASER congress. The study was carried through in Prague by Med. Dr. Miroslav Prochzka and Renata Tejnska. The study displays that Ginkgo Biloba in combination with LASER reduced tinnitus completely among 26% of the patients in the study. 36% had their tinnitus reduced by more than half, 19% had their tinnitus reduced by up to 50% and only 19% had no effect at all. In total it means that 81% had a noticeable improvement in their tinnitus and 62% of the treated patients had considerable relief of their tinnitus. In the control group where placebo LASER was used, not one single patient was relieved of tinnitus. In the treatment there were much larger doses administrated towards the inner ear than in any recent blind study. The patients were treated during six months. The patients in the LASER group were treated in three treatment series with ten treatments per series. The randomization was based upon coincidence, which in this case meant that what group the patients would be part of depended on which LASER device was free when they arrived for their first treatment. The patients didn't know if they received true LASER or placebo LASER, and neither did the therapists. The LASER manufacturer Medicom revealed what was LASER and what was placebo LASER after finishing the study and breaking the code. The study has been published on the Internet together with many other controlled LASER studies. RESULTS AFTER THE TREATMENT OF TINNITUS SYMPTOMS GROUP 1 Ginkgo Biloba + Rehabilitation GROUP 2 Ginkgo Biloba + Rehabilitation + Placebo-LASER 26 % 48 % 26 % 0% GROUP 3 Ginkgo Biloba + Rehabilitation + Functional LASER 19 % 19 % 36 % 26 %

No effect Less than 50 % lessening More than 50 % lessening No more tinnitus

29 % 44 % 18 % 9%

The results of the controlled, double blind LASER therapy study conducted by Miroslav Prochzka & Renata Tejnska.

M. PROCHZKA & A. HAHN - RESEARCH ABOUT TINNITUS TREATMENT In Comprehensive Laser Rehabilitation Therapy of Tinnitus: Long-Term Double Blind Study in a Group of 200 Patients in 3 Years Miroslav Prochzka, Med. Dr., Private Rehab Clinic Jarov, Prague, CZ and PhD, Med. Dr. Ale Hahn, Head of the ENT Clinic, FNKV Faculty Hospital, Prague, CZ present even better results than in Prochzka and Tejnska's first tinnitus study. Prochzka and Hahn's study is carried through over a longer period of time and also includes many more patients than the first study. The second study also displays that patients getting a small but obvious positive treatment effect after one treatment period in many cases get an improved treatment effect after repeated therapy. These therapeutic experiences are shared by all doctors who are today using the LASER therapy method on inner ear patients. Ale Hahn has also conducted a LASER treatment study on tinnitus symptoms. A link to this extended tinnitus study by Miroslav Prochzka and PhD Ale Hahn is found at Laser Partner. RESULTS AFTER THE TREATMENT OF TINNITUS SYMPTOMS GROUP I (6 months) Ginkgo Biloba + Rehabilitation + Functional LASER 19 % 19 % 36 % 26 % GROUP II (3 years) Ginkgo Biloba + Rehabilitation + Functional LASER 16 % 15 % 43 % 26 %

No effect Less than 50 % lessening More than 50 % lessening No more tinnitus

The table above displays the results of the controlled, double blind LASER therapy study on tinnitus symptoms conducted by Miroslav Prochzka & Ale Hahn. Miroslav Prochzka is lecturing about the LASER therapy method for the treatment of tinnitus. He is also reporting his observations in tinnitus treatment in Case Histories of Patients Suffering from Tinnitus Treated by Comprehensive Rehabilitation Therapy Including LLLT. M. QUITTNER - RESEARCH ABOUT TINNITUS TREATMENT Mark Quittner, in a clinical study during the summer of 2004, treated 32 patients whose tinnitus symptoms were evaluated before and after therapy. In the study 29 (91%) of the 32 patients had diminished tinnitus symptoms after repeated LASER treatment sessions. The best results were found among the patients who received 240-480 J. The article describing the study was published in 2004 by the Swedish Laser Medical Society in Laser World as Guest Editorial. Michael Zazzio has together with Bill Verran and Mark Quittner been planning a double blind, controlled, randomized study with a control group. If and when the study will be carried through has not been decided. Permission to start the study has not been received.

Y. SHIOMI - RESEARCH ABOUT TINNITUS TREATMENT Another study, carried through at an otolaryngology department at a medical institute in Kyoto in Japan in 1997 by the researchers Yosaku Shiomi, Takahashi, Honjo, Kojima, Naito and Fujiki, displayed that tinnitus therapy with LASER had a positive effect on more than half of the patients in the study. The LASER light was administrated towards the cochlea via the hearing canal, and the conclusion was that LASER is worth trying on patients suffering from tinnitus symptoms. 55% of the patient population in the study had a diminished effect from the LASER treatment and no permanent or serious complications were observed. In the study, 26% of the LASER-treated patients had a permanent improvement in their tinnitus despite the low LASER doses administrated (21 Joule). Y. SHIOMI - RESEARCH ABOUT COMPOUND ACTION POTENTIAL A study measuring CAP (Compound Action Potential) was also carried through in Kyoto, Japan in 1995 by Yosaku Shiomi. The study was made on ears from a guinea pig and displayed that LASER exposure of the cochlear hair cells had an immediate effect on the impulse flow in the nerve cells. When the LASER light was turned off the impulse flow went back to normal levels. The changing in impulse flow proves that immediate processes take place in the inner ear when it is irradiated by LASER light. S. TAUBER - RESEARCH ABOUT TINNITUS TREATMENT In a controlled, double blind study published in 2001 by Stefan Tauber, A. De Nigris, K Schorn, R Baumgartner, and W Beyer at the institution of otolaryngology at the Ludwig-Maximillian University in Mnich, LASER therapy using 630 nm, 690 nm and 830 nm wavelengths had a positive effect on tinnitus symptoms. In the study every patient received LASER light during only three treatment sessions. Despite that, between 20 % and 40 % of the patient population had a diminished tinnitus in the groups receiving LASER from these wavelengths. Not one single patient of the 125 patients in the study was negatively affected by the treatment. The study also included a light dosimetric analysis measuring how much of the administrated LASER light is reaching the cochlea when the LASER light is administrated via the ear canal. Different LASER light frequencies were absorbed differently on their way to the sensory cells of the cochlea. S. TAUBER - RESEARCH ABOUT TINNITUS TREATMENT In 2003 Stefan Tauber, K Schorn, R Baumgartner, and W Beyer presented another positive study on the positive effects of LASER light on tinnitus symptoms. In this study the patients received LASER therapy on five occasions, and after six months a follow up procedure was made on the tinnitus symptoms of the patients. 13 out of 35 patients (37%) still had improvements in their tinnitus symptoms six months after the treatment. 2 patients got rid of their tinnitus symptoms. These results were measured despite the few treatment sessions and despite the fact that the evaluation was made six months after finished therapy.

T. KARU - RESEARCH ABOUT LASER THERAPY A combination of 635 nm and 820-830 nm LASER light is, according to studies conducted by Prof. Tiina Karu, in a positive way affecting both RNA synthesis, DNA synthesis and the cell contact between cells. The cell repair work is stimulated by LASER light. If 820-830 nm LASER light is excluded in therapy, the effects in the RNA synthesis in the cells brings along that the transport function via the cell membranes is not as much stimulated as if they are used. If 635 nm LASER light is excluded, the positive effects in DNA synthesis affect the dividing rate of the cells. The cell contact between cells is stimulated by both wavelengths. Also, the ATP production is affected positively by LASER light. These effects have a major importance for cell respiration and for many processes in the cells and their ability to function normally. Apart from the work of Tiina Karu there are hundreds of LASER studies describing processes that support cell repair. A. HAHN - RESEARCH ABOUT TINNITUS TREATMENT A tinnitus study conducted by PhD. Med. Dr. Ale Hahn, I Sejna, K Stolbova, A Cocek at the Karlovy University Hospital in Prague, the Czech Republic showed an improvement of tinnitus symptoms for 50,8% of the LASER treated chronic patients, suffering from tinnitus for more than 10 years. The study was published in Acta Otolaryngol 2001. In another publication Ale Hahn's study was divided into three groups. A comparison was made between LASER and Ginkgo Biloba. The study was based upon the Lurias scale. Each patient had a start value of their symptoms of the value 10. The evaluation was made after both three and six weeks after starting the treatment and the results are displayed in the table below. RESULTS AFTER THE TREATMENT OF TINNITUS SYMPTOMS Start value Value after 3 weeks of treatment Value after 6 weeks of treatment GROUP 1 Ginkgo Biloba 10 8 7 GROUP 2 Ginkgo Biloba + LASER 10 4 5 GROUP 3 LASER 10 6 5

The controlled study of Ale Hahn where tinnitus symptoms were treated with LASER and Ginkgo Biloba. All groups in the study were improved. In the combined Ginkgo Biloba / LASER group the improvements were found to be the greatest. Every group consisted of 35 patients.

L. WILDEN - RESEARCH ABOUT HEARING TREATMENT Lutz Wilden is the pioneer in LASER therapy on inner ear diseases who showed that large doses of LASER light were more beneficial than low doses administrated in earlier LASER studies. Lutz Wilden has shown that larger doses have a positive effect on a larger number of patients suffering from hearing impairment than smaller LASER light doses. Lutz Wilden has together with Dirk Ellerbrock conducted a study on patients with impaired hearing. The study was carried through with large doses of LASER light and displayed good results. The hearing capacity was improved for patients suffering from hearing impairment with an average of 7,8 dB after twelve treatment sessions on the approximately 400 ears that were treated in the study. The studies of Lutz Wilden also display that tinnitus symptoms are diminished or disappear for many patients who are treated with LASER light. Lutz Wilden has together with D. Dindinger conducted a positive clinical study on LASER treatment of tinnitus symptoms. Lutz Wilden has in research also been pointing out processes in the mitochondria, processes related to the increase of cell energy production when LASER light is administrated. In another study, Lutz Wilden has together with R. Karthein been studying LASER therapy on tinnitus symptoms. 67% of the patients got better in their tinnitus symptoms. P. MARTI - RESEARCH ABOUT TINNITUS TREATMENT In 2001 Peter Marti made a pilot study with the combined method including LASER therapy, electromagnetic therapy and negatively ionized oxygen ions. The study was conducted on 18 patients suffering from tinnitus symptoms. In the study 61% got rid of their tinnitus symptoms, another 33% had an obvious improvement in their tinnitus and 6% had a minor improvement. 94% of the patients had a major improvement or got rid of the symptoms. All patients in this pilot study had improvements. The study included 16 treatments per patient. Every treatment session lasted approximately 40 minutes. The LASERs emitted 830 nm and 635 nm wavelengths of LASER light and were administrated via the ear canal. J. HUBACEK - RESEARCH ABOUT TINNITUS TREATMENT Jiri Hubacek has been reporting his LASER medical experiences from otorhinolaryngology in "Experience with the use of LLLT in ENT Medicine". In the report there are two groups consisting of 60 tinnitus patients, 30 in each group. The patients were treated with LASER from 10 to 30 sessions. 35% of the treated patients got rid of their tinnitus, and 40% had their tinnitus symptoms reduced. There were no treatment effects on tinnitus for 25% of the treated patients. R. JUBERG - RESEARCH ABOUT TINNITUS TREATMENT Robin Juberg has been treating patients in Molde in Norway in cooperation with Ingunn Rogne at "Tinnituskontakt" in Mre og Romsdal and Harald Sbstad, the leader of "Kristiansund og Omegn Hrselsforening". The study shows that 87% of the treated patients had a noticeable change in their tinnitus and 60% of the patients had a great reduction (more than 40% reduction) of their tinnitus.

13% didn't receive any treatment effect.

U. WITT - RESEARCH ABOUT TINNITUS TREATMENT There are many studies supporting positive effects after using LASER therapy on inner ear disorders and ear-nose-throat-dysfunctions, and there are many reports from doctors in private practice. Med. Dr. Uwe Witt has collected the following results for a report:

Researcher
Prof. Zechner Dr. Osterwald Prof. Danielidis Dr. Witt Prof. Kramp

Place
Wien, Austria Hannover, Germany Saloniki, Greece Hamburg, Germany Rostock, Germany

Positive effect among the patients

>50 % 56 % 57 % 58 % 60 %

Source: Med. Dr. Uwe Witt, Hamburg