EarCell

Investigational Use Only – We strive to recover hearing with treatments of bioelectric stimulation alone, preferably non-invasively, and resort to more serious treatment options such implantable bioelectric stimulators with implantable leads, micro infusion pumps and repeat delivery of our proprietary EC-15 fifteen component hearing regeneration composition, only when non-invasive bioelectric stimulation has not been fully effective in restoring hearing.

Our patented and patent pending bioelectric stimulation signals do the following:

• SDF-1 = stem cell homing signal, promotes blood vessel maturation
• IGF-1 = promotes DNA repair and regeneration.
• EGF = promotes regeneration.
• HGF = promotes blood vessel growth and regeneration.
• PDGF = stem cell homing signal, promotes blood vessel formation, promotes regeneration.
• VEGF = promotes blood vessel formation.
• HIF 1 Alpha = promotes blood vessel formation.
• eNOS = dilates blood vessels.
• Tropoelastin = promotes improved elasticity of tissues.
• Follistatin = promotes regeneration particularly of muscle.
• GDF-10 + 11 = promotes regeneration particularly of neuronal cells and nerves.
• IL-1, 3, 6, 9 = helps manage healing and inflammation.
• Proliferation = multiples recruited and injected stem cells.
• Differentiation = converts recruited stem cells to useful local tissue.

Our EC-15 hearing regeneration composition is comprised of these components:

• Adipose tissued derived stem cells = promotes blood vessel growth and regeneration.
• Amniotic fluid = full of regeneration promoting growth factors.
• Selected exosomes = promote blood vessel growth and regeneration.
• Selected micro RNAs = promotes regeneration.
• Selected alkaloids = promotes neuronal and nerve regeneration.
• Nutrient hydrogel = promotes healing and regeneration, reduces cell loss.
• Organ specific matrix = promotes stem cell recruitment and regeneration.

Our FluidSynch micro infusion pump was developed in collaboration with Fluid Synchrony LLC of Pasadena, CA with over $2 million in National Science Foundation Small Business Innovation Research funding. It is under the size of a nickel and can slowly infuse cells, growth factors and other fluids into any organ include the inner ear. The micro pump is programmable and re-fillable and can be ordered with one or two filling chambers. This pump can easily be hidden by a persons ear when in place .

Our bench top models 240 and 740 have FDA 510K market clearance for improving blood circulation, accelerated healing, improving muscle tone and for mild pain relief. These devices about the size of a personal computer. Our micro implantable device was developed in collaboration with QIG Greatbatch that invested more than $50 million in its development. The device is about the size of a quarter now. The team is working to reduce it soon to the size of a dime. The micro implantable device is available for investigational use only at this time.

Hearing loss can be due to several factors such as the aging process, exposure to loud noise, medications, infections, head or ear trauma, congenital (birth) or genetic factors, diseases, as well as a number of other causes. Recent data shows that about 20 percent of adults in the United States (48 million) report some degree of hearing loss. Hearing loss often occurs gradually throughout a lifetime.

If you have any symptoms of hearing loss, you should see a hearing instrument specialist to have a formal hearing evaluation. This hearing test allows the hearing instrument specialist to determine the type, nature and degree of your hearing loss and provide an indication as to how successful of a candidate you will be for hearing aids.

The hearing evaluation will also include a thorough case history and a visual inspection of the ear canal and eardrum. The results of the evaluation can be useful to a physician, if the hearing instrument specialist believes your hearing loss may benefit from medical intervention.

Results of the hearing evaluation are plotted on a graph called an audiogram. The audiogram provides a visual view of your hearing test results across various pitches or frequencies, especially the ones necessary for understanding speech.

The audiogram and results from your speech understanding tests are used to create a prescription by which hearing aids are programmed, if necessary.

After you undergo a hearing evaluation, the results are plotted on a chart called an audiogram. Loudness is plotted from top to bottom. The top of the graph is very quiet and the bottom of the graph is very loud. Frequency, or pitch, from low to high, is plotted from left to right. Hearing level (HL) is measured in decibels (dB) and is described in general categories, not by percentages. The general hearing loss categories used by most hearing professionals are as follows:

• Normal hearing (0 to 25 dB HL)
• Mild hearing loss (26 to 40 dB HL)
• Moderate hearing loss (41 to 70 dB HL)
• Severe hearing loss (71 to 90 dB HL)
• Profound hearing loss (greater than 91 dB HL)

There are four types of hearing loss:

1. Sensorineural hearing loss: When the problem is in the inner ear, a sensorineural hearing loss is the result. This commonly occurs from damage to the small hair cells, or nerve fibers, in the organ of hearing. Sensorineural hearing loss is the most common type of hearing loss and accounts for more than 90 percent of hearing loss in all hearing aid wearers. The most common causes of this hearing loss are age-related changes and noise exposure. Loss may also result from disturbance of inner ear circulation, increased inner ear fluid pressure, or from disturbances of nerve transmission. There are many excellent options for the patient with sensorineural hearing loss.

2. Conductive hearing loss: When there is a problem in the external or middle ear, a conductive hearing impairment occurs. Conductive hearing loss occurs when sound is not conducted efficiently through the ear canal, eardrum, or tiny bones of the middle ear, resulting in a reduction of the loudness of sound that is heard. Conductive losses may result from earwax blocking the ear canal, fluid in the middle ear, middle ear infection, obstruction of the ear canal, perforation (hole) in the eardrum membrane, or disease of any of the three middle ear bones. All conductive hearing losses should be evaluated by a physician to explore medical and surgical options.

3. Mixed hearing loss – When there are problems in the middle and inner ear, a mixed hearing impairment is the result (i.e. conductive and a sensorineural impairment).

4. Auditory neuropathy spectrum disorder (ANSD): The least common hearing impairment is ANSD. This type of loss requires more in-depth diagnostic testing, including a hearing evaluation with pure tones, otoacoustic emissions (OAEs) and auditory brainstem response (ABR) testing. In this type of hearing loss, the nerve fibers in the organ of hearing typically appear to be functioning well, but a breakdown of the information occurs along the pathway to the brain. A person may still have normal hearing to sounds, but the sound is not encoded properly the brain. This type of hearing disorder is diagnosed more often in children, due in part to newborn hearing screenings that use automated ABR equipment and routine speech screenings by pediatricians and school systems, but can be present in adults as well.

WARNING: EarCell products are Investigational Use Only at this time and are not yet proven to be safe or effective in statistically significant randomized, blinded, placebo controlled trials. Not available for sale.