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(standard deviation = 14%). 92% of subjects completing the study (35 out of 38) perceived a clinically
significant improvement for Earlens relative to unaided as measured by APHAB.
8.4. Temporary TM Damping
The Lens is designed to remain in place even when the Processor is not worn. When the Processor is
removed (while swimming, bathing, or sleeping), users may experience TM damping, which would be
interpreted as slight reduction of sound, due to the loading effect of the Lens. The effect on PTA (500 Hz,
1000 Hz and 2000 Hz) averaged 4 dB, which is immediately reversed when the Lens is removed. When
the Processor is in place, the gain delivered by the Earlens Hearing Aid more than overcomes the TM
damping effect.
8.5. Summary of Extended Study
The safety and effectiveness of the Earlens Hearing Aid was monitored beyond the 4 months of the
Definitive Study. In the Extended Study, 24 subjects (48 ears) opted to continue wearing the Earlens
Hearing Aid after completing the Definitive study. At the conclusion of the Extended Study, 33 ears had at
least 12 months of cumulative Lens wear with no change in unaided air conduction hearing thresholds
under earphones. Of the 24 active subjects in the Extended Wear Study, 11 related adverse events (AEs)
AEs were experienced by 8 subjects in 10 ears. All events were temporary and resolved. Nine of 11 AEs
were related to ear cleaning pre-impression (3 AEs), the impression procedure (4 AEs), or the inspection
process pre-impression (2 AE). Two of the related AEs were attributed to Light Tip fit and both were
resolved after Light Tip modification. One subject continues to report a sensation of fullness.
Driven on the results of the Definitive study, the Earlens Hearing Aid has been shown to be safe and
effective in delivering the full spectrum of amplification from 125Hz to 10,000Hz.
9. Operating Instructions
9.1. Processor and Light Tip Fitting Procedure
Earlens provides Processors and customized Light Tips for each patient. The Light Tip is designed to fit
deeply into the patient's ear canal, like an IIC or CIC. It is very important that it is placed properly and fits
well to ensure consistent sound amplification. Physical modifications of the Light Tip shell or cable may
be necessary to achieve improved comfort/fit.
All Light Tips include an indicator, red for the right and blue for the left.
Placement of the Processor and Light Tip
a. Place the Processor behind the patient's ear.
b. Hold the Light Tip between your thumb and index finger and gently insert it into the ear canal, taking
care not to over-insert it.
c. The Light Tip should be aimed down the length of the ear canal towards the Lens.
d. Once fully inserted, the Light Tip should fit snugly but be comfortable for the patient.
e. If necessary, physical modifications of the Light Tip shell or the shape of the Light Cable may be
necessary to achieve improved comfort or fit.
NOTE- Modify with caution, being careful not to damage or alter the orientation of the emitter
embedded in the Light Tip.
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