IFU00022vJ
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6. Warnings
Before using the Earlens Hearing Aid, make sure you and your patients read and understand
each of the following safety warnings:
•
The Earlens Hearing Aid is considered MR unsafe. The Lens should be removed prior to an MRI
exam or MRI exposure.
Only physicians trained in Ear, Nose & Throat procedures should
place or remove the Lens.
•
The patient should not use therapeutic or medical diathermy using electromagnetic radiation
(magnetic induction coils or microwave) from the shoulders up with Earlens Hearing Aid in place.
•
The Processor and Light Tip unit contain a Class 1 laser product. It is safe to
use under normal operating conditions. The Class 1 laser light is NOT visible.
Do NOT look directly into the laser or aim directly into the eyes. Should any
part of the Aid become damaged, the patient should discontinue use and
contact their hearing professional.
•
If the patient experiences discomfort or pain in their ear, they should contact their ENT physician
immediately. Only physicians trained in Ear, Nose & Throat procedures should place or remove
the Lens.
•
The patient should not insert foreign objects into the ear, such as Q-tips, bobby pins or
fingernails. Insertion of foreign objects could result in pain and damage to the ear, damage to the
Lens or cause it to operate improperly.
•
The patient should contact their hearing professional if they experience discharge from the ear or
persistent discomfort or any other problems.
•
Should the Processor become unusually warm or hot, the patient should promptly remove it,
discontinue use and contact their hearing professional.
•
Do not crush, short circuit, modify or disassemble any component of the Earlens Hearing Aid.
Keep all components of the Earlens Hearing Aid out of the reach of children, pets and others, to
avoid risk of swallowing.
•
Do not incinerate any component of the Earlens Hearing Aid or use near open flame. Handle
waste from electronic equipment per local regulations.
7. Precautions
Before using the Earlens Hearing Aid, make sure you and your patients read and understand
each of the following safety precautions.
•
Individuals with known nickel sensitivity/allergy should be informed that the Lens component
contains nickel that is coated with a parylene barrier. If an allergic reaction develops, the Lens
should be promptly removed.
•
The Earlens Lens was tested for nickel leaching and found to be compliant and within the safe
levels identified in European standard EN1811. Traces of oxidation (discoloration) may be visible
on the Lens surface following prolonged wear. Testing indicated the oxidation was not likely to
affect the structural integrity of the Lens within the 1 year expected life.
•
Only hearing professionals trained in the fitting of hearing aids may fit the Earlens Processor and
Light Tip.
•
The Earlens Hearing Aid is custom designed and intended to be used for a single patient.
•
The Light Tip is designed to sit a set distance from the Lens. Sound output may deviate if the
Light Tip is not inserted to the proper depth. If the sound output does deviate, the patient can
reposition the Light Tip until optimal sound output is achieved.
•
Earplugs or headphones can be used with the Lens in place as long as care is taken not to over-
insert them and they do not protrude deeply into the ear canal.
•
The patient may shower, bathe or swim with the Lens in place. Ear plugs may be used to prevent
water from entering the ears so long as care is taken to not over-insert them. Removing water
from ears may be more difficult with the Lens in place.
Class 1 Laser
Product
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