Clinical Study Information - Earlens Contact Hearing Solution User Manual

no guarantee that interference will not occur in a particular installation. If this equipment does
cause harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:
− Reorient or relocate the receiving antenna.
− Increase the separation between the equipment and receiver.
− Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
− Consult the dealer or an experienced radio/TV technician for help.
®
Earlens Contact Hearing Solution complies with part 18 of the FCC rules.
Summary of Wireless Technologies
The Earlens® Contact Hearing Solution incorporates two wireless technologies. One is an
inductive link to transmit data and power from the Processor and Ear Tip to the Tympanic Lens.
The second is a Bluetooth streaming link that supports Apple Made for iPhone (MFi) audio
streaming for hearing aids.
60

Clinical Study Information

The following section includes technical terminology that may be unfamiliar to you. If you have any
questions, contact your physician or hearing health care professional.
The Definitive Clinical Study of the Earlens® Contact Hearing Solution confirmed the safety and
Before using the Earlens ® Contact Hearing Solution, make s
effectiveness of the Earlens® Contact Hearing Solution for individuals with a mild to severe
Before using the Earlens ® Contact Hearing Solution, make s
sensorineural hearing impairment between the frequencies of 125 Hz-10,000 Hz. The prospec-
tive, single arm study assessed 48 subjects (96 ears) who wore the fully activated Earlens®
Contact Hearing Solution in both ears in their daily lives for four months per study protocol.
Safety and effectiveness were assessed during the four months.
Study Demographics
The average age of the study population was 69 years with a gender ratio of 60% for males and
40% for females. All participants were experienced hearing aid users.
Before using the Earlens ® Contact Hearing
61