IFU00021vH
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Earplugs or headphones can be used with the Lens in place as long as care is taken not to over-
insert them and they do not protrude deeply into the ear canal.
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The patient may shower, bathe or swim with the Lens in place. Ear plugs may be used to prevent
water from entering the ears so long as care is taken to not over-insert them. Removing water
from ears may be more difficult with the Lens in place.
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If the patient has small or unusually shaped ear canals, they may be at greater risk for ear canal
abrasions, either from the ear impression procedure or from Light Tip use.
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The patient should avoid getting the Processor wet, as it may damage the device. The patient
must remove the Processor prior to showering, swimming, or bathing.
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The patient may experience a reduction in their hearing levels when the Lens is in place but the
Processor is not activated.
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Do not direct streams of liquid (i.e. isopropyl alcohol, hydrogen peroxide, DeBrox) into ears, as
this may cause the Lens to become dislodged or cause damage to the device.
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Failure to oil the ear canal may result in Lens displacement.
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Do not place any component of the Earlens Hearing Aid into a microwave, or near a significant
source of static electricity.
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Use only the Earlens Charger and AC wall adapter provided. Although other adapters may look
similar, they may cause damage to the Earlens Hearing Aid.
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Handle the components carefully and prevent hard knocks. Do not drop them as it may damage
the Earlens Hearing Aid.
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If the Earlens Processor fails to operate or if it appears damaged, including the presence of
battery leakage or swelling, the patient should promptly remove the Processor, discontinue use
and contact their hearing professional.
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Only clean the Processor with a soft cloth. Do not use chemicals (i.e. hairspray) in close proximity
or to clean the Processor.
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Keep Charger cord out of reach of individuals who may be at risk of strangulation.
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Electromagnetic fields produced by other electrical equipment such as cell phones, metal
detectors, microwaves, RFID systems and commercial theft detection systems (also known as
electronic article surveillance [EAS]) may interfere with the Earlens Hearing Aid. In the event that
the patient perceives unexpected noise or interference in the presence of the Earlens Hearing
Aids, move away from the source to mitigate the potential interference. If the patient has further
concerns they should remove the Processors and contact their hearing professional.
8. Clinical Study Results
The Definitive Clinical Study of the Earlens Light Driven Hearing Aid confirmed the safety and
effectiveness of the Earlens Hearing Aid for individuals with a mild to severe sensorineural hearing
impairment between the frequencies of 125 Hz – 10,000 Hz. The prospective, single arm study assessed
48 subjects (96 ears) who wore the fully activated Earlens Hearing Aid in both ears in their daily lives for
four months per study protocol. Safety and effectiveness were assessed during the four months.
8.1. Study Demographics
The average age of the study population was 69 years with a gender ratio of 60% for males and 40% for
females. The subjects were seen across three clinical sites with the largest enrollment at Site 1 (Site 1=
21, Site 2=15 and Site 3=12). All participants were experienced hearing aid users.
8.2. Safety Outcomes
The primary safety endpoint was intended to demonstrate that use of the Earlens Hearing Aid did not
result in a change in residual hearing function. The objective was to identify any change in baseline
hearing after four months of device usage using a four frequency threshold criteria (500, 1000, 2000, and
4000 Hz, referred to as PTA4). A determination of clinically non-significant hearing threshold change was
made if calculated PTA4 hearing change of the subject population was less than 10 dB. After wearing the
Lens for 4 months, no decrease in hearing sensitivity of more than 10 dB was observed. A secondary
safety endpoint assessed any decrease in hearing sensitivity of >10 dB by subject per ear at each test
frequency. After four months of use no subjects exhibited a decrease of >10 dB for either ear at any
