Earlens Contact Hearing Solution User Manual page 33

The primary safety endpoint was intended to demonstrate that use of the Earlens® Contact
Hearing Solution did not result in a change in residual hearing function. 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 at either ear by
frequency.
No serious device or procedure-related adverse events were reported during the trial. There were
31 adverse events (AEs) reported in 20 subjects for 22 ears. All but one of the adverse events
were temporary and resolved. One subject report of a 'fullness' sensation when wearing the
Earlens® Contact Hearing Solution did not change during the trial. Effectiveness outcomes were
sing the Earlens ® Contact Hearing Solution, make s
not impacted and the subject continued device use throughout the study period of four months.
Table 1 identifies the adverse events by type, frequency of occurrence and resolution status at the
conclusion of the study.
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Safety Outcomes Safety Outcomes
Before using the Earlens ®
Adverse Events
Adverse Event Category
Abrasion/blood blister in ear canal
Contact Hearing Solution, make s
Ear discomfort/pain
Inflammation/granulation tissue on tympanic membrane
Abrasion/blood blister on tympanic membrane
Ear tip-related: ear canal swelling, itching, etc.
Pain upon eructation & valsalva
Sensation of fullness
The primary efficacy endpoint was intended to demonstrate device effectiveness by improving
speech recognition using the Northwestern Auditory Test No.6 (NU-6) test of word recognition
Before using the Earlens with the Earlens® Contact Hearing Solution at a speech level of 45 dB HL. The objective was to
show that the Earlens® Contact Hearing Solution provides a statistically significant improvement
Before using the Earlens
in mean aided word recognition at 30 days post placement when compared to the baseline
unaided condition measured prior to placement.
Number Occuring
17
5
3
2
2
1
1
Effectiveness Outcomes
® Contact Hearing Solution, make s
® Contact Hearing Solution, make s
Serious AE Status
No
Resolved
No
Resolved
No
Resolved
No
Resolved
No
Resolved
No
Resolved
No
Ongoing
63