Device Labeling Symbols - Earlens Contact Hearing Solution User Manual

Summary of Extended Study
The safety and effectiveness of the Earlens® Contact Hearing Solution was monitored beyond the
Before using the Earlens
4 months of the Definitive Study. In the Extended Study, 24 subjects (48 ears) opted to continue
wearing the Earlens® Contact Hearing Solution after completing the Definitive study. At the
Before using the Earlens ® Contact Hearing Solution, make s
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 Ear Tip fit and both were resolved
after Ear Tip modification. One subject continues to report a sensation of fullness.
Based on the results of the Definitive study, the Earlens® Contact Hearing Solution has been
Before using the Earlens
shown to be safe and effective in delivering the full spectrum of amplification from 125Hz to
10,000Hz.
66
®
Contact Hearing Solution, make s
® Contact Hearing Solution, make s

Device Labeling Symbols

earlens.com/ifu
Refer to
Instruction
By Prescription
Only
Ingress
Protection
Code
44
You should not use therapeutic or medical diathermy
Date of
Serial Number Catalog Code
Ingress
Protection Batch Code
Code
67