EarLaser4

What is Tinnitus?

Perception of sound in the ear when no outside sound is presented. Sound can be heard as ringing, buzzing, clicking, cricket, popping, water rushing, pulsating or roaring.

How Tinnitus happens?

Many disorders arise through a deficiency of ATP (adenosine triphosphate), the cell energy necessary for life. ATP is a key substance in our cells. The mitochondria (cell power-plants) provide ATP energy for the cell processes through glucose combustion. ATP deficiency leads to cell damage and destruction at the end. Concentrated Laser light stimulates glucose combustion to improve the ATP supply. The laser therapy can therefore accelerate the regeneration of damaged cells in the auditory system

Some facts about Tinnitus

More than 70% of those have tinnitus have poor sleeping
Almost 50% of those have tinnitus, they experience the symptoms across 80% of the day
Hearing loss is often linked to tinnitus
More than 70% of those have tinnitus have reduced life quality
More than 500 million people suffer from tinnitus worldwide

No tinnitus is the same as another

Results from a new study show that almost a quarter of the population has already experienced a “ringing in the ears” at one time or other. Almost 10% hear these sounds in their ears uninterruptedly for five minutes or longer. With 3% one can speak of chronic tinnitus. The earlier treatment begins, the greater the chances of a successful cure.
Our goal is to give you the best possible overview of the treatment possibilities for tinnitus and for similar inner ear disorders, such as partial deafness due to tinnitus, ear pressure, dizziness (morbus Ménière), vertigo, acute hearing loss and hearing distortion. In collaboration with affected persons and with specialists we are researching and developing new forms of therapy and evaluating their chances of success.
The most important and encouraging information is the fact that tinnitus has a benign cause in 99% of all cases. It can be regarded as a natural risk of modern living and a part of the aging process. Do not lose hope. With our years of experience, we’ve been able to help with success over 40,000 affected people. We will try to advise you objectively and to inform you about the most promising of the treatment possibilities.

EarLaser4

The principle of EarLaser4 is to project the needed energy concentratedly and precisely on the ailing area by means of an elaborate fiberglass cable. With the optimized EarLaser4; we set new standards regarding product quality and ease of handling. Due to the perfect positioning of the EarLaser4 beam can reach the inner ear more exactly.

The treatment with the EarLaser4 is completely safe and painless. The laser beam even penetrates the deeper subcutaneous layers and works as curative bio-stimulation directly on the metabolism in the connective tissue. This leads to rapid regeneration of the hearing cells, stimulation of the immune system, acceleration of cell division and activation of specific defensive molecules. More than 40,000 affected persons have already been successfully treated with this system.

Operation Instructions

The MedicLaser in conjunction with the EarTool can be used for the following applications:
• Ear pressure: 1 x per day, 2 minutes, for at least 3 weeks
• Tinnitus: 1 x per day, 2 minutes, for at least 10 weeks
There is an extensive instruction manual enclosed, which explains all treatment methods simply and in detail.
The treatment time may be extended, depending on the degree of severity.

Certificates and Accreditation

Our products and our business are subject to the most scrupulous ISO 13485 quality checks. Both have been certified in accordance with the strict guidelines for medical devices. We have CE marking and operate in accordance with EU guidelines 93/42/EWG. Our work is supervised by the Swiss accreditation body and is therefore directly affiliated to the European Accreditation System.

• TinniTool ProfiLaser meets requirements as per:
• ISO 13485 + 14971
• CE (Europa) 93/42/CEE
• CB (Internazionale) IEC-EN 60601
• ETL (USA/ Canada) UL 60601
• IEC 60601-1 = Medical electrical equipment: General requirements for safety
• IEC 60601-1-2 = Medical electrical equipment: General specifications for safety
• IEC 60601-1-6 = Medical electrical equipment: General requirements for basic safety and essential performance – Col-lateral standard: Usability
• IEC 60601-1-11 = Medical electrical equipment: General requirements for basic safety and essential performance
• IEC 60825-1 = Safety of laser devices: classification of facilities and requirements
• IEC 62366 = Medical devices – Application of usability engineering to medical devices
• IEC 980 = Graphical symbols for labeling of medical devices

Risk analysis in accordance with DIN-EN-1441 and EN-ISO-14971

Patented softlaser technology for treating tinnitus associated inner ear disorders

With this patented Swiss Soft Laser technology a solution was found for treating tinnitus (ringing in the ears) yourself and similar inner ear disorders, such as partial deafness due to tinnitus, ear pressure, morbus Ménière (dizziness), acute hearing loss and hearing distortion.
The Soft Laser System consists of the MedicLaser (5mW output power and 650nm wavelength) and the headset EarTool (fiberglass optical fiber in the ear). The device was conceived so that treatment could be carried out at home (without medical knowledge). The laser treatment accompanying the therapy is especially promising.
The treatment with the TinniTool EarLaser is completely safe and painless. The laser beam even penetrates the deeper subcutaneous layers and works as curative bio-stimulation directly on the metabolism in the connective tissue. This leads to rapid regeneration of the hearing cells, stimulation of the immune system, acceleration of cell division and activation of specific defensive molecules. More than 40’000 affected persons have already been successfully treated with this system.
Many disorders arise through a deficiency of ATP (adenosine triphosphate), the cell energy necessary for life. ATP is a key substance in our cells. The mitochondria (cell power-plants) provide ATP energy for the cell processes through glucose combustion. ATP deficiency leads to cell damage and destruction in the end, but concentrated MedicLaser light (650 nm wavelength) stimulates glucose combustion to improve the ATP supply. The MedicLaser and EarTool therapy can therefore accelerate the regeneration of damaged cells in the auditory system.
The principle of EarTool (headset) is to project the needed energy from the MedicLaser concentratedly and precisely on the ailing area by means of an elaborate fiberglass cable. With the optimized EarTool we set new standards regarding product quality and ease of handling. The new EarTool fits better on the head and is more comfortable. Due to the perfect positioning of the EarTool the laser beam can reach the inner ear more exactly. An additional inner-ear treatment with laser-acupuncture increases the effect of the EarLaser. Detailed instructions for self-treatment are enclosed with the EarLaser. In the case of chronic tinnitus, sleep disturbances and difficulty in relaxation, the treatment should be accompanied by the acoustic therapy.
The laser treatment underwent successful long-term testing in hospitals and in physician practices. It was submitted to extensive medical tests and proven scientifically by various medical studies. The safety and effect of the EarLaser were attested and certified medically.

Suitable with symptoms like:

• Acute and chronic tinnitus since 3 years
• Partial deafness due to tinnitus
• Morbus Ménière (dizziness)
• Acute hearing loss and hearing distortion
• Consequences of a middle ear inflammation
• Circulatory problem in the inner ear

Technical data:

• Output power: 5 mW
• Wavelength: 650 nm
• Treatment time: ca. 20 minutes per day
• Skin penetration: ca. 1.8 cm
• Warranty: 2 years
• Battery operation: 2 x 1.5V (LR03 AAA)
• Laser protection class: 2M
• Medical device class: IIa
• Medical device testing: CE (Europe), CB (International), ETL (USA/Canada)
• Patents: CH (699352), EU (06761280.4), Intern. (PCT/CH 2006/000429)