Studi clinici

Low level laser per pazienti affetti da tinnito

Valutazione del grado di soddisfazione di chi utilizza il TinniTool MedicLaser

Finn Andersen, Gabriele Deterville, IHA-GfK, Certificato ISO-9001, in base alle norme Swiss-Interview

The IHA-GfK is the most renowned market research institute in Switzerland. The results reported in this performance are 100% significant for the target group surveyed.

141 patients were interviewed after treatment with the MedicLaser+TinniTool. The results are promising, as it can be seen that other therapies known on the market are far from these values.

The TinniTool soft laser is 96% used to treat tinnitus. 56% do not know the cause of the disorders. The main cause of the disorders is illness, work-related and military stress. 42% of the respondents used the TinniTool soft laser for 3 months. For 65% of the interviewees, the disorders were reduced by up to 25%; for 20%, between 25% and 49%; for 9%, they were reduced between 50% and 100%. The longer the treatment, the better the success. The average degree of satisfaction with the TinniTool soft laser is above average by 4.8 points (on a scale of values between 0 and 9). Satisfaction with the TinniTool soft laser increases as the duration of the treatment increases and the degree of interference reduction increases. 18% also use the TinniTool soft laser to treat other disorders such as limbs, acne, scars and arthrosis. Respondents who also use the TinniTool soft laser for other treatments were satisfied with 6.38 points (on a scale from 0 to 9), which is a good result overall. Satisfaction increases as the duration of the treatment increases. 54% of the respondents would buy back the TinniTool soft laser. 67% would recommend the TinniTool soft laser to others.

Low-Level Laser Terapia per il trattamento degli acufeni con TinniTool EarLaser

Dott. Domenico Cuda, Dott. Antonio R. de Caria, Unità Operativa di ORL - Ospedale di Piacenza / Pubblicato nel "International Tinnitus Journal" Vol.14, No.2, 175-180 (2009)

Without doubt the most indicative study for the treatment with the TinniTool Earlaser is the one carried out in Italy. The center for the treatment of tinnitus of the ENT department of the clinic of Piacenza, has performed as part of a double-blind research, on 46 patients (27 were male and 19 female) affected by tinnitus a therapy with the TinniTool EarLaser. These cold light lasers had a power of 5mW and a wavelength of 650 nm.

Measurements were evaluated with the unified evaluation system THI (Tinnitus Handicap Inventory, by Dr. Newman). The improvement after the treatments was significant. Equally significant was the difference between the experimental group and the placebo group. The results show an improvement in 88% of patients. In 62 % of the people treated the improvement was remarkable (for one class according to THI), in another 11.6 % the improvement was excellent (for two classes according to THI).

Efficacia della terapia-Softlaser applicata al trattamento del Tinnitus e della perdita uditiva neurosensoriale

Dr Mohammad-Al-Masri, Ph.D.; Lina Abu Knader, MSc., Mohammad Tawalbeh, AL-Ahliyya Amman University

Recently, low-energy ophtlaser therapy has become an alternative therapy for the treatment of chronic tinnitus and neurosensory capacity loss of hearing. This clinical study was performed on 32 adult patients who had been suffering from tinnitus for more than three months. These patients were treated with the TinniTool EarLaser, some of them also complained of high blood pressure, diabetes, hearing loss and chronic heart problems. The Softlaser has a power of 5 milliwatts and a wavelength of 650 nm. The duration of each treatment session is 20 minutes per day.

The results show significant improvements in both tinnitus and hearing loss recovery. Eighty-eighty-eight percent of the patients undergoing treatment achieved a 25% improvement in relation to tinnitus intensity. In 47 % of patients the tinnitus disappeared completely. In addition, in 66 % of patients, hearing loss improved by 5 decibels at a constant level of 250-8000 Hz and above. In 10 % of patients, an improvement of more than 20 decibels was achieved. At the end of this clinical study, it can be confirmed that low-frequency laser therapy with the TinniTool EarLaser is a very effective treatment method for treating tinnitus and improving sensorineural hearing loss.

Low-Level Laser Terapia (LLLT) per il trattamento degli acufeni

Dott. R. Teggi, Dott. C. Bellini, Dott. M. Bussi, IRCCS San Raffaele - Università Vita e Salute - Milano

The therapeutic results obtained with LLLT were compared with the results of a placebo group; n definitive will be of 30 patients per group, currently data referred to n=13 per therapeutic group and n=16 per control group. Randomized, double-blind study; laser of the placebo group completely identical to the group that performed therapy but did not emit therapeutic light. Application of home LLLT with TinniTool for 20 minutes a day for 4 months. Laser characteristics: 5mw, 650 nm, total absorbed energy for application 6 Joule/c.

Conclusion: Improvement of the “physical” characteristics of tinnitus; decreased Loudness. No side effects recorded. Acufen after therapy is more easily masked and decrease patients suffering from hyperacusia. The latter data suggest the possible use of LLLT associated with TRT to improve the parameters that most hinder the success of therapy with sound enrichment.

TinniTool Terapia laser a basso livello nei pazienti con disturbi da tinnito

Ahmed H Salahaldin, Khalid Abdulhadi, Nihal Najjar, General Hospital, Hamad Medical Corporation, Qatar

The study included 65 patients aged 15 – 76 years with chronic tinnitus from a minimum duration of illness of one year. The investigation included 101 ears of 65 patients. A 5mW laser with a wavelength of 650 nm was applied for 20 minute once daily for 3 months.

Over half of the patients (56.9%) had some form of improvement in their tinnitus symptoms. Mild improvement was reported in 33.8% of patients; moderate improvement was reported in 16.9% and full improvement was reported by 6.15% of patients. In patients who reported dizzy spells as a symptom of their tinnitus condition, 27.7% reported mild improvement and 16.9% reported full improvement. Conclusion : Low level laser therapy was found to be useful for treatment of chronic tinnitus.

Revisión de Resultados de la Terapia Laser TinniTool de Bajo Nivel de Estimulación

Juan Carlos Olmo, M.Ed. Magíster, Instituto Costarricense de Audiología Clínicas de la Audición, Costa Rica

Twenty-two known patients with long-standing chronic tinnitus, aged between 36 and 61 years, who had received prior specialized ENT medical treatment without positive results to reduce tinnitus discomfort, were followed. This group of patients acquired the Tinnitool device, with the characteristics described above.

These are preliminary results of the study in such cases: Improvement = 45 %, Disappearance = 20 %, No Change = 35 %. Low Level Laser Stimulation therapy has been shown to be effective in 59% of cases of subjective tinnitus, surpassing the percentages of any placebo in the investigations. Conclusion: It is a valid alternative for patients who have tried to find a solution by medical and surgical means without success.

Terapia con láser de bajo nivel TinniTool: Características y mediciones subjetivas del tinnitus

Prof. M. Savastano (MD), L. Termine (Tech), V. Prosenikliev (MD), University of Padua (IT)

This study considered 49 consecutive tinnitus sufferers, 24 females (mean age 57 years) and 35 males (mean age 54 years), observed by the ENT Section of the Department of Medical-Surgical Specialities of Padua University. In the study were included all tinnitus sufferers who sought help from an ENT Specialist only for this symptom. All patients underwent the application of a Soft Laser system, consisting in a Medical Laser with 5mW output power and 650nm wavelength and the headset EarTool (fibreglass optical fibre in the ear), applied to all the patients 1 x per day, 20 minutes, for three months. The device was conceived so that treatment could be carried out at home. As control group were considered 10 subjects who underwent the application of a Laser placebo, without any radiation, with the same modality of the sample group. Moreover tinnitus annoyance was studies using the Tinnitus Handicap Inventory (THI) which help to identify the degree of problems that tinnitus may be causing.

The intensity of tinnitus ranged between 10-20 db in 6 subjects (12,24%), 25-40 db in 13 (26,53%), 40-60 db in 22 (44,89%), 60-70 db in 4 (8,16%), 70- 90 db in 4 (8,16%). The intensity resulted between 10-20 db in 5 subjects(10,20%), 25-40 db in 17 (34,69%), 40-60 db in 19 (38,77%), 60-70 db in 3 (6,12%), 70-90 db in 3 people (6,12%), not perceived in 2 people (4,08%). Conclusion: In our study the most relevant effect is the reduction of tinnitus intensity in the group of patients who underwent the treatment with active laser. In this group it was observed a statistically significant reduction in tinnitus intensity threshold after LLT therapy.

Terapia con láser de baja intensidad para el tinnitus

Peng Z, Yiu-Qi Chen, Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, China

This is one of a number of tinnitus reviews. The paragraphs are based on earlier work.

Description of the intervention:
LLLT is non-invasive, painless and can be easily administered in primary care settings. LLLT acts by inducing a photochemical reaction in the cell, a process referred to as biostimulation. It is an irradiation technique that has the ability to induce biological processes using photon energy. There are studies showing proliferation and angiogenesis. Most evidence of efficacy is based on the increase in energy state and the activation ofmitochondrial pathways. It has been reasonably well established that mitochondria are a principal intracellular target of red and near infrared light. In recent years, LLLT has been widely used in the treatment of tinnitus. These laser beams are cool to the touch and do not cause discomfort. They are aimed into the auditory canal and through the mastoid bone behind the ear. The wavelength nature of these lasers allows them to penetrate tissue.

How the intervention might work:
The prevailing opinion is that the respiratory chain plays a central role in the effect induced by laser therapy. Laser energy in the red and near infrared light spectrum is capable of penetrating tissue. It stimulates mitochondria in the cells to produce energy through the production of adenosine triphosphate (ATP). Mitochondria are the power supplies of all cells; they metabolise fuel and produce energy for the cell in the form of ATP. It has been reported that LLLT irradiation increases the production of ATP. Increased ATP production may lead to enhanced cell metabolism, promoting the damage recovery process, returning cells to a healthy state and reversing many degenerative conditions. For ear disorders, low-level laser has been reported to alter the collagen organisation within the cochlea, especially within the basilar membrane. Also, LLLT has a beneficial effect on the recovery of cochlear hair cells after acute hair cell loss, increases cell proliferation, synthesis of ATP and collagen, release of growth factors, promotes local blood flow in the inner ear and activates repair mechanisms in the inner ear through photochemical and photophysical stimulation of the hair cell mitochondria.

Primary outcomes:
• Improvement in tinnitus severity and disability

Secondary outcomes:
• Improvement of quality of life
• Change in socio-economic impact associated with work
• Change in anxiety and depression disorders
• Change in psychoacoustic parameters
• Change in tinnitus loudness
• Change in overall severity of tinnitus
• Change in thresholds on pure-tone audiometry

Terapia con láser de bajo nivel en pacientes con disfunción coclear crónica

Dr. Stefan Tauber et al., HNO-Universitätsklinik und Laser Forschungslabor, Universität München

In a double-blind placebo-controlled study low-level-laser light was applied to 175 patients with chronic tinnitus. The patients received 3 single irraditations with different diode-laser with 635-830 nm and dosages from 4 to 100 Joule/cm2.

Low-level laser therapy for chronic tinnitus has been well tolerated without side effects. In general higher dosages caused to a stronger attenuation of tinnitus.

In comparison to placebo:
– tinnitus loudnes is improved by laserlight of 780 nm
– tinnitus is attenuated by laserlight between 690 and 830 nm concerning visual analogue scales of 5 different parameters.
– total tinnitus score has been improved by irradiation with laserlight of 635 up to 830 nm.
Regarding those results, tinnitus-laser offers an innovative ans secure way of effective tinnitus treatment in patients with chronic tinnitus. Tinnitus-laser are a new therapeutic system for chronic cochlear tinnitus without risk of side-effects.

Correlatos neuronales del láser coclear transmeatal (TCL)

Christian M. Siedentopf, Department of Radiology II, Division of Neuroradiology, University Hospital of Innsbruck, Austria

Transmeatal cochlear laser (TCL) treatment has recently been proposed as a therapeutic procedure for cochlear dysfunction such as chronic cochlear tinnitus or sensorineural hearing loss. The aim of this study was to investigate whether TLC has any influence on the central nervous system using functional MRI with healthy young adults. The laser stimulation device was placed on the tympanic membrane of both ears. A laser stimulation run and a placebo run were performed in random order. The participants were unable to differentiate between verum and placebo stimulation. In the comparison of verum to placebo runs, we observed significant activations within the left superior frontal gyrus, the right middle and medial frontal gyrus, the right superior parietal lobule, the left superior occipital gyrus, the precuneus and cuneus bilaterally, the right anterior and the left and right middle and posterior cingulate gyrus and the left thalamus. This network of brain areas corresponds well to results from previous PET studies of patients with tinnitus. Though TCL seems to have a clinically measurable effect on the central nervous system the neurophysiological mechanism leading to the observed activated neuronal network remains unknown.

Studio di penetrazione laser ex-vivo

Dr. Beyer, Dr. Tauber

Dr. Beyer & Dr. Tauber have 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/cm2 in the cochlea itself. Irradiation via the mastoid showed values 103 to 105 times smaller (depending on wavelength) than irradiation through the tympanic membrane. 35 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.

Terapia completa dei pazienti affetti da tinnito

M. Prochazka, R. Tejnska

37 patients suffering from tinnitus (age 18-86 years) were treated in three ways: 1. Rehabilitation: mobilisation, physical training, physiotherapy. 2. Same as 1 but with placebo laser added. 3. Same as 1 but with functional laser added. Laser used was 830 nm 300 mW. 2-3 treatments per week were given, total 10 treatments. Treatment protocol: 90 J/cm2 CW on mastoideus, 45 J/cm2 5 Hz on mastoideus, 50 J/cm2 CW on acoustic duct, 25 J/cm2 5 Hz on acoustic duct. 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. The percent wise outcome for the three groups was: 1.29.4/44.1/17.6/8.9 2. 25.8/48.4/25.8/0 3. 19.4/19.4/35.5/25.8 Auris Nasus Larynx. 1997; 24 (1): 39-42.

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 J/cm2 behind the ear. The outcome was: no more tinnitus 26%, more than 50% relief 43%, less than 50% relief 15%, no effect 16%. In 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, with laser/no laser: no more tinnitus 25.8%/0.0%, more than 50% relief 35.5%/25.8%, less than 50% relief 19.4%/48.4%, no effect 19.4%/25.8%.

Terapia laser combinata a basso livello e estratto di ginkgo biloba come prova alla cieca per il trattamento del tinnito

Olivier J., Plath P., Laser Therapy, 5:137-139, 1993, John Wiley & Sons, Ltd.

Tinnitus is a troublesome and often debilitating complaint of neuro-otologic origin, but of indefinite cause. Many treatment methods have been tested, but so far none have been really successful. The present preliminary study reports on a blind trial with 40 patients, 20 each in a trial group and in a control group, who were treated with laser therapy in combination with the intake of a ginkgo biloba extract.

All 40 patients received a biloba extract injection, but only the 20 trial patients actually received laser irradiation, eight days a day for eight minutes.

The control group received only fake irradiation. From the experimental group, 50% reported that their tinnitus was reduced by more than 10 dB compared to 5% in the control group for both self-assessment and audiometric results.

Although this is only a preliminary report, the results are very encouraging and the authors recommend this combined photochemotherapy as a promising treatment for tinnitus.

Efficacia dell'irradiazione laser transmeatal a bassa potenza per l'acufene cronico

Gungor A, Dogru S, Cincik H, Erkul E, Poyrazoglu E.; Department of Otolaryngology, Haydarpasa Military Hospital, Istanbul, Turkey.

Objective: To evaluate effectiveness of 5 mW laser irradiation in the treatment of chronic tinnitus. Study design: Prospective, randomised, double-blind study. Methods: This investigation included 66 ears in 45 patients with chronic unilateral or bilateral tinnitus. A 5mW laser with a wavelength of 650 nm, or placebo laser, was applied transmeatally for 15 minutes, once daily for a week. A questionnaire was administered which asked patients to score their symptoms on a five-point scale, before and two weeks after laser irradiation. A decrease of one scale point, regarding the loudness, duration and degree of annoyance of tinnitus, was accepted to represent an improvement.

Results: The loudness, duration and degree of annoyance of tinnitus were improved, respectively, in up to 48.8, 57.7 and 55.5 per cent of the patients in the active laser group. No significant improvement was observed in the placebo laser group.

Conclusion: Transmeatal, low power (5 mW) laser irradiation was found to be useful for the treatment of chronic tinnitus.

Laser a infrarossi applicato nel meatus acousticus acousticus

Prof. Shiomi

Prof. Shiomi 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.

Durata media dell'acufene di 10 anni

Dr. Hahn

Dr. Hahn examined 120 patients with an average duration of tinnitus of 10 years. The patients underwent pure-tone 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, 20 dB in 22, 30 dB in 10, 40 dB in 6 and 50 dB in 5 patients.