Instructions for Use

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.


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).


AUDIOMETRIC FITTING RANGE: The audiometric fitting range for the Earlens Hearing Aid is shown in the Figure below.