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2.3. Earlens Fitting Software (ELF)
ELF is used to program the Processor, enabling the hearing professional to calibrate and program the
Processor specific to the patient's needs.
2.4. Earlens Charger and Power Adaptor
The Charger is designed to recharge the Processors
(Figure 5). When connected to the wall power
adaptor, the Charger houses and chargers either
one or two Processors simultaneously. An AC wall
power adaptor is included.
2.5. Earlens Impression System
The Earlens Impression System is used by the
physician to collect a deep ear canal impression. The
impression is used to manufacture the customized
Lens and Light Tip.
2.6. Mineral Oil
White mineral oil (food grade) is used to lubricate the
eardrum to keep the Lens in place and functioning
properly. To maintain the devices, it is recommended
that patients apply at least two pumps of mineral oil
to their ears twice a week.
3. Indications for Use
The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by
vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild
to severe sensorineural hearing impairment who can benefit from amplification. The device can provide
the full spectrum of amplification that includes 125 Hz – 10,000 Hz.
4. Fitting Range
The Earlens Light Driven Hearing Aid provides the full spectrum
of amplification that includes 125 Hz – 10,000 Hz. The
audiometric fitting range for the Earlens Hearing Aid is shown in
Figure 6.
5. Contraindications
The patient must not have any known or active medical issues
that would preclude having a hearing device, including:
a. an abnormal TM (deemed perforated, inflamed or has
dimeric or monomeric area, or in any other way
abnormal);
b. an abnormal middle ear or a history of prior middle ear
surgery other than tympanostomy tubes;
c. an ear canal anatomy that prevents the physician from
seeing an adequate amount of the TM;
d. an anatomical configuration of the external auditory canal that
prevents satisfactory placement of the Lens;
e. a history of chronic and recurrent ear infections in the past 24 months;
f.
a rapidly progressive or fluctuating hearing impairment;
g. diagnosed with having a compromised immune system which may impact the tissue of the auricle
or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or
received radiation of the head ever or chemotherapy for cancer within the last six years.
Figure 5: Earlens Charger
Figure 6: Earlens Fitting Range
IFU00021vH
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