Clinical studies

about low level lasers for tinnitus patients

Evaluation of the customer satisfaction among users of the TinniTool MedicLaser

Finn Andersen, Gabriele Deterville, IHA-GfK, ISO-certified (ISO-9001), in accordance with the standards of Swiss-Interview

The IHA-GfK is the most renowned institut of market study in Switzerland. The results given and statements made in this presentation correspond 100% to the data collected and are fully valid.

A total of 141 patients were interviewed. After the MedicLaser + TinniTool treatment, the results were very promising. It has been shown and can be assessed that other known marketed therapies did not reach the same value.

The Soft Laser TinniTool is used to treat tinnitus in 96% of cases. 56% do not know the cause of this complaint. The main causes of the complaint were named as illness, stress and work, as well as serving in the armed forces. 42% of the respondents had used the Soft Laser TinniTool for 3 months. For 65% of those affected, the complaint had been reduced by up to 25%, for 20% between 25% and 49% and, for 9%, by 50%-100%. The longer the period of use, the greater the success of the treatment. On a scale of 0 to 9, satisfaction with the Soft Laser TinniTool achieved an over average of 4.8. Satisfaction with the Soft Laser TinniTool increased in proportion to the length of use as well as with the extent to which the complaint had been reduced. 18% also used the Soft Laser Tinnitool for other forms of treatment, such as for joints, acne, scars and arthrosis. The satisfaction of those respondents who had also used the Soft Laser TinniTool for other forms of treatment achieved overall a good score of 6.38 on a scale of 0 to 9. Overall satisfaction with the Soft Laser TinniTool increased with length of use. 54% of the respondents would buy the Soft Laser TinniTool again. 67% would recommend the Soft Laser TinniTool to others.

Low-level laser therapy for the treatment of tinnitus with TinniTool EarLaser

Dr. Domenico Cuda, Dr. Antonio R. de Caria, ENT Department, Piacenza Clinic, Italy / Published in the "International Tinnitus Journal" Vol.14, No.2, 175-180 (2009)

Without a doubt the most convincing study for the treatment with the TinniTool EarLaser was conducted in Italy. The Tinnitus Treatment Centre at the ENT Department of the Piacenza Clinic carried out a therapy with the TinniTool EarLaser on 46 tinnitus patients (27 male, 19 female) within the scope of a double-blind study. This cold-light laser had a power rating of 5 MW and a wavelength of 650 nm.

The measurements were evaluated with the standardised evaluation system THI (Tinnitus Handicap Inventory, according to Dr. Newman). The improvement after the treatments was significant. Also significant was the difference between the test group and the placebo group. The results show a treatment success amongst a total of 88% of those involved. With 62% of the treated individuals, the improvement was distinctive (in 1 class according to THI); with another 11.6%, the improvement was even outstanding (in 2 classes according to THI).

The effectiveness of soft laser therapy for tinnitus and sensory hearing loss

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

Recently, low level laser irradiation is becoming alternative therapeutic procedures for treatment cochlear dysfunction such as chronic tinnitus and sensorineural hearing loss. This study was conducted on 32 adults who are suffering from tinnitus using TinniTool EarLaser device to evaluate the effectiveness of soft laser therapy for treatment tinnitus. The subjects were suffering from continuous tinnitus for more than 3 month and some of them had hypertension, Diabetics Miletus, hearing loss, and chronic heart disease. The subjects had received a laser power of 5mW and the wavelength 650 nm for 20 minutes a day for 10 weeks.

The results show remarkable improvement in both tinnitus intensity and the degree of hearing loss. 88% of the subjects reported the tinnitus intensity reduced more than 25% and 47% of the subject had complete recovery from tinnitus. Additionally, 66% of the subjects had an average improvement in hearing thresholds at 250-8000Hz more than 5 dB and 10% of the subjects the average was more than 20 dB. It was concluded from this study that soft laser therapy is very effective for treatment of tinnitus and sensorineural hearing loss.

TinniTool Low level laser therapy in patients with complaints of tinnitus

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

Se realizó seguimiento a 22 pacientes conocidos portadores de acúfenos crónicos de larga data, con edades entre 36 y 61 años, quienes habían recibido tratamiento médico especializado ORL previo sin resultados positivos para disminuir la molestia del Acúfeno. Este grupo de pacientes adquirió el dispositivo Tinnitool, con las características descritas anteriormente.

Estos son resultados preliminares del estudio en dichos casos: Mejora = 45 %, Desaparición = 20 %, Sin Cambio = 35 %. La terapia Laser de Bajo Nivel de Estimulación ha demostrado ser eficaz en un 59 % de los casos de acúfenos subjetivos, superando los porcentajes de cualquier placebo en las investigaciones. Conclusión: Es una alternativa válida para pacientes que han intentado encontrar solución por medios médicos y quirúrgicos sin éxito.

TinniTool Low Level Laser Therapy: Tinnitus subjective characteristics and measurements

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.

Low-level laser therapy for 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

Low-level-laser-therapy in patients with chronic cochlear dysfunction

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

In a double-blind placebo-controllesd 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 loudness 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 and secure way of effective tinnitus treatment in patients with chronic tinnitus. Tinnitus-lasers are a new therapeutic system for chronic cochlear tinnitus without risk of side-effects.

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

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

I risultati terapeutici ottenuti con LLLT sono stati confrontati con i risultati di un gruppo placebo; n definitivo sarà di 30 pazienti per gruppo, attualmente dati riferiti a n=13 per gruppo terapeutico e n=16 per gruppo controllo. Studio randomizzato, in doppio cieco; laser del gruppo placebo del tutto identico al gruppo che effettuava terapia ma non emettente luce terapeutica. Applicazione di LLLT domiciliare con TinniTool per 20 minuti al giorno per 4 mesi. Caratteristiche del laser: 5mw, 650 nm, energia totale assorbita per applicazione 6 Joule/c.

Conclusioni: Miglioramento delle caratteristiche “fisiche” dell’acufene; Loudness diminuita. Peraltro non variazioni statistiche dei valori di THI e delle scale VAS. Nessun effetto collaterale registrato. Acufene dopo terapia è più facilmente mascherabile e diminuiscono i pazienti affetti da iperacusia. Questi ultimi dati suggeriscono il possibile impiego della LLLT associata alla TRT per migliorare i parametri che maggiormente ostacolano il successo della terapia con l’arricchimento sonoro.

Neural correlates of transmeatal cochlear laser (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.

Ex-vivo laser penetration study

Dr. Beyer, Dr. Tauber

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/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.

Comprehensive therapy of patients suffering from Tinnitus

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%.

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 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 middle-ear 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, 20 mW cw, n=18) with a space irradiation of 4 J/cm2 site of maximal cochlear injury. 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 TCL-system 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. Used by permission of the Czech Society for the Use of Laser in Medicine.

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 helium-neon 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.

Dr. 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, 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. 5 irradiations within 2 weeks each with a space irradiation of 4J/cm2 were applied at the 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.

Effectiveness of transmeatal low power laser irradiation for chronic tinnitus

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.

Infrared laser applied into the meatus acousticus

Prof. 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.

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 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.