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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 Adapter
The Charger is designed to recharge the Processor (Figure 5).
When connected to the wall power adapter, the Charger houses
and charges either one or two Processors simultaneously. An AC
wall power adapter is included with the system.
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
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.
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).
(a.k.a. Earlens Hearing Aid)
Aid
Figure 5: Earlens Charger
amplified sound by
transmits
Figure 6: Earlens Fitting Range
IFU00022vJ
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