Studi clinici

La IHA-GfK è il più rinomato Istituto di ricerche di mercato della svizzera. I risultati riportati in questa prestazione sono 100% significativi per il target intervistato.

141 pazienti sono stati intervistati dopo il trattamento con il MedicLaser+TinniTool. I risultati sono promettenti, poiché si può accetare che altre terapie conosciute sul mercato sono molto lontane da questi valori.

Il soft laser TinniTool è utilizzato al 96% per curare gli acufeni (tinnito). Il 56% non conosce la causa dei disturbi. La causa principale dei disturbi è dovuta a malattia, stress-lavoro e militare. Il 42% degli intervistati ha utilizzato il soft laser TinniTool per una durata di 3 mesi. Per il 65% degli intervistati i disturbi si sono ridotti fino al 25%; per il 20% tra il 25 e il 49%; per il 9% si sono ridotti tra il 50% e il 100%. Quanto più dura il trattamento, tanto migliore è il successo ottenuto. Il grado di soddisfazione medio riferito al soft laser TinniTool è sopra la media, di 4.8 punti (su una scala di valori tra 0 e 9). La soddisfazione riferita al soft laser TinniTool cresce con l’aumentare della durata del trattamento e con il grado di riduzione dei disturbi. Il 18% usa il soft laser TinniTool anche per curare altri disturbi come per esempio gli arti, l’acne, le cicatrici e l’artrosi. La soddisfazione degli intervistati che utilizzano il soft laser TinniTool anche per altri trattamenti è pari a 6.38 punti (su una scala da 0 a 9), ossia un risultato complessivamente buono. La soddisfazione cresce con l’aumentare della durata del trattamento. Il 54% degli intervistati ricomprerebbe il soft laser TinniTool. Il 67% consiglierebbe ad altri il soft laser TinniTool.

Senza dubbio lo studio più indicativo per il trattamento con il TinniTool Earlaser è quello effettuato in Italia. Il centro per il trattamento del acufeni del reparto ORL della clinica di Piacenza, ha eseguito nell’ambito di una ricerca doppio cieco, su 46 pazienti (27 erano di sesso maschile e 19 di sesso femminile) colpiti dell’acufene una terapia con il TinniTool EarLaser. Questi laser a luce fredda disponevano di una potenza di 5mW e una lunghezza d’onda di 650 nm.

Le misurazioni sono state valutate con il sistema di valutazione unificato THI (Tinnitus Handicap Inventory, di Dr. Newman). Il miglioramento dopo i trattamenti è risultato significante. Ugualmente significante era la differenza tra il gruppo sperimentale e il gruppo placebo. I risultati mostrano un miglioramento nell'88% dei pazienti. Nel 62 % delle persone trattate il miglioramento è stato notevole (per una classe secondo THI), in altri 11,6 % il miglioramento è stato eccellente (per due classi secondo THI).

Recentemente la terapia-Softlaser a bassa energia é diventata una terapia alternativa per il trattamento dell’acufene cronico e della perdita della capacità neurosensoriale dell’udito. Questo studio clinico é stato effettuato su 32 pazienti adulti, sofferenti di acufene da oltre tre mesi. I suddetti pazienti sono stati trattati con il TinniTool EarLaser, alcuni di loro lamentavano inoltre pressione alta, diabete, perdita dell’udito e problemi cronici al cuore. Il Softlaser dispone di una potenza di 5 milliwatt e una lunghezza d’onda di 650 nm. La durata di ogni seduta terapeutica é di 20 minuti al giorno.

I risultati evidenziano miglioramenti notevoli sia in relazione all’acufene che al recupero di perdita uditiva. L’88 % dei pazienti in cura hanno ottenuto un miglioramento del 25 % in relazione all’intensità dell'acufene. Nel 47 % dei pazienti l’acufene è scomparso totalmente. Inoltre al 66 % dei pazienti, è migliorata la perdità dell’udito di 5 decibel ad un livello costante di 250-8000 Hz in su. Il 10 % dei pazienti hanno raggiunto un miglioramento di oltre 20 decibel. A conclusione di questo studio clinico, si può confermare che la terapia laser a bassa frequenza con il TinniTool EarLaser, é un metodo di trattamento assai efficace per la cura del acufene e per migliorare la perdita dell’udito neurosensoriale.

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. 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.

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.

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.

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.

Background:
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

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.

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.

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.

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 ist eine lästige und oft schwächende Beschwerde neuro-otologischen Ursprungs, aber unbestimmter Ursache. Viele Behandlungsmethoden wurden erprobt, aber bisher war keine wirklich erfolgreich. Die vorliegende vorläufige Studie berichtet über einen Blindversuch mit 40 Patienten, je 20 in einer Versuchs- und in einer Kontrollgruppe, die mit der Lasertherapie in Kombination mit der Einnahme eines Ginkgo-Biloba-Extraktes behandelt wurden.

Alle 40 Patienten erhielten eine Biloba-Extrakt-Injektion, aber nur die 20 Versuchspatienten bekamen tatsächlich Laserbestrahlungen, acht Tage lang täglich acht Minuten.

Die Kontrollgruppe erhielt nur eine vorgetäuschte Bestrahlung. Von der Versuchsgruppe gaben 50 % an, dass sich ihr Tinnitus um mehr als 10 dB reduziert habe, verglichen mit 5 % in der Kontrollgruppe sowohl bei der Selbsteinschätzung als auch bei den audiometrischen Ergebnissen.

Obgleich es sich nur um einen vorläufigen Bericht handelt, sind die Ergebnisse sehr ermutigend, und die Autoren empfehlen diese kombinierte Fotochemotherapie als vielversprechende Behandlung des Tinnitus.

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.

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.

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.