IFU00021vH
4
Note: Once the otologic and audiologic indications for use were met, approximately 95% of patients were
successfully fit with the Earlens Hearing Aid (5% were unable to anatomically accommodate the Lens).
6. Warnings
Before using the Earlens Hearing Aid, make sure you 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 Earlens Hearing 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 the patient 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 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 healthcare 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.
Class 1 Laser
Product
