IFU00021vH
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An additional measure of device effectiveness was perceived benefit as measured by the Abbreviated
Profile of Hearing Aid Benefit (APHAB). The average baseline unaided percentage of communication
difficulties was 58% (standard deviation = 16%), the percentage of difficulties decreased to 30%
(standard deviation = 13%) with the subject’s own air conduction hearing aid, and for Earlens it was 29%
(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 (swimming, bathing, 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 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 125 to 10,000Hz.
9. Operating Instructions
9.1. Ear Canal Impression
Before making the ear canal impression using the Earlens Impression System, please read and follow the
precautions and procedures found in the Earlens Impression System Instructions for Use.
9.2. Lens Placement
a. Visually inspect the Lens packaging. DO NOT use if there is any visible damage.
b. Explain to the patient that the ear will be inspected and cleaned, then lubricated with oil (which
may cause some sensations of stuffiness), and the device will be inserted. Instruct the patient to
remain still during the procedure.
c. With the patient in the supine position, use a binocular microscope to inspect the external
auditory canal and the tympanic membrane and determine if there are any contraindications for
Lens placement.
d. Remove all cerumen and epithelial debris from the ear canal, anterior sulcus and tympanic
membrane using the usual office instrumentation and small cotton swabs with mineral oil. If there
is any bleeding or development of contraindications as a result of cleaning of the ear canal, do
not place Lens.
e. Lubricate the ear canal and TM with mineral oil.
f.
Read the package label to confirm that the device is for the right patient and ear (Left or Right).
The right device is identified by a red dot. The left device is identified by a blue dot. In addition to
the label, the Grasping Tab is located on the right side of the Photodetector for a right-ear device
and on the left side of the Photodetector for a left-ear device.
g. Grasp the Lens at the Grasping Tab (Figure 2) using smooth alligator forceps.
