Evaluation of the customer satisfaction among users of the EarNoiseEliminator MedicLaser
IHA-GfK, Finn Andersen, Gabriele Deterville, 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 +
EarNoiseEliminator 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 EarNoiseEliminator 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 EarNoiseEliminator 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 EarNoiseEliminator achieved an over
average of 4.8. Satisfaction with the Soft Laser EarNoiseEliminator
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
EarNoiseEliminator 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 EarNoiseEliminator 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 EarNoiseEliminator increased
with length of use. 54% of the respondents would buy the Soft Laser
EarNoiseEliminator again. 67% would recommend the Soft Laser
EarNoiseEliminator to others.
Low-level laser therapy for the treatment of tinnitus with EarNoiseEliminator EarLaser
Dr. Domenico Cuda, Dr. Antonio R. de Caria, ENT Department, Piacenza Clinic, Italy
Without a doubt the most convincing study for the treatment with the
EarNoiseEliminator EarLaser was conducted in Italy. In 2007, the
Tinnitus Treatment Centre at the ENT Department of the Piacenza Clinic
carried out a therapy with the EarNoiseEliminator 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).
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 EarNoiseEliminator 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.
(On request this study is available in italian language.)
Double-blind study for 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.
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. 30 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.
