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h. Using alligator forceps, gently advance the Lens through a thin bladed nasal speculum to the
medial region of the ear canal.
i.
Then, using an aural speculum and curved pick, gently advance the Lens onto the TM and
position it such that the Perimeter Platform is congruent with the anatomical contours of the
patient's anatomical counterparts. At this point the Umbo platform will be in direct contact with
the TM.
j.
Once satisfactory positioning is achieved, remove the speculum.
k. Verify functionality of the Lens after placement in the patient's ear using the Earlens Light Pen.
Please read and follow the precautions and procedures found in the Earlens Light Pen
Instructions for Use.
9.3. Lens Removal
a. Explain to the patient that the ear will be inspected and cleaned, lubricated with mineral oil (which
may cause some sensations of stuffiness), and the device will be gently removed. Instruct the
patient to remain still during the procedure.
b. With the patient in the supine position use a binocular microscope to inspect the external auditory
canal and the TM, and determine the position of the device and the location of the grasping tab.
c. Lubricate the ear canal with mineral oil.
d. Using a right angle hook, use the Grasping Tab to capture the device to be removed and slowly
deliver it into the lateral canal. Withdraw the speculum, and use the curved pick to remove the
Lens.
e. Inspect the external auditory canal and the TM.
9.4. Cleaning and Preparing the Lens for Reinsertion
If a Lens is removed the device and canal must be cleaned prior to reinsertion of the device.
a. Remove the Lens per the Lens Removal instructions and carefully place the device in a dish of
mineral oil for soaking.
b. Thoroughly clean the ear canal, anterior sulcus and TM using cotton swabs, mineral oil and
suction as needed. Remove any debris, including epithelial tissue that may have built up in the
anterior sulcus or on the TM.
I.
Hydrogen peroxide solution can be used to loosen hard epithelium or cerumen adhered
to the TM or anterior sulcus. Before placement of the Lens ensure all of the hydrogen
peroxide is completely suctioned out, and the applied area is cleaned with mineral oil, to
avoid device contact with the hydrogen peroxide solution.
c. Inspect the umbo of the TM and the area where the Perimeter Platform of the Lens was resting to
ensure it is free of debris or epithelial tissue.
d. After soaking, grasp the Lens at the Grasping Tab using alligator forceps under visual
magnification. Carefully suction any debris remaining from the Perimeter Platform and/or
Photodetector.
I.
Avoid directly contacting the support springs and Umbo Platform while cleaning the Lens.
II.
Holding the Grasping Tab of the Lens with the alligator forceps prevents the Lens from
being suctioned up, dropped to the floor or experiencing undue pressure on the Umbo
Platform. It also aids to control the suction to the Lens.
e. Following the cleaning carefully inspect the Lens to ensure it is free of debris and is not damaged.
I.
Replacing a Lens that is not free of debris or is damaged may cause the device to
displace.
f.
Proceed with device placement per the Lens Placement operating instructions.
9.5. Troubleshooting
The expected life for the Lens is one year. The Lens is expected to exhibit the same failure modes
regardless of the duration of wear. The Lens can become displaced from the tympanic membrane,
blocked by debris or degrade over time. This may cause the sound output of the Earlens Hearing Aid to
IFU00021vH
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