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Intended use
Intended Use:
An air conduction hearing aid is a wearable sound-amplifying device intended to
compensate for impaired hearing. Hearing aids are available in multiple gain/output
levels appropriate to treat hearing losses ranging from mild to profound.
Your hearing aids are designed to operate in public and residential environments
and are designed to comply with international Electromagnetic Compatibility
emissions and immunity standards for medical devices. However, it is still possible
that you may experience interference caused by power line disturbances, airport
metal detectors, electromagnetic fields from other medical devices, radio signals
and electrostatic discharges.
If you use other medical devices or wear implantable medical devices such as
defibrillators or pacemakers and are concerned that your hearing aids might
cause interference with your medical device, please contact your physician or the
manufacturer of your medical device for information about the risk of disturbance.
Your hearing aids should not be worn during an MRI procedure or in a hyperbaric
chamber or other oxygen-rich environments.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.
Your hearing aids are not formally certified to operate in explosive atmospheres such
as may be found in coal mines or certain chemical factories.
Your hearing aids should be stored and transported within
95% rH
45˚C
the temperature, humidity, and pressure ranges of -40°C
(-40°F) to +60°C (140°F), 10%-95% rH, and 70 kPa–106 kPa
10% rH
-10˚C
(equivalent to altitudes from 1,200 ft (380 m) below sea
level to 10,000 ft (3,000 m).
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from -20°C (-4°F) to +50°C (122°F).
The expected service life is 3 years.
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Intended use
CAUTIONS:
• If the product is hot, do not touch it until cool.
• If the product is not working, do not disassemble. Due to a shock hazard, please
send in for repair.
• Keep out of reach from children. Do not ingest anything in the package, including
desiccant, cleaning tool, etc.
Clinical benefit
The hearing aid is designed to provide better speech understanding to help ease
communication with the aim of improving quality of life.
Clinical Study Summary
A clinical study, including adults aged 18 years and over with hearing losses ranging
from mild to profound, assessed hearing aid performance and benefit. Over the
course of 2-6 weeks of device wear, users completed various laboratory and field
assessments to determine if the devices met clinical expectations. The results of
the study confirm that the devices provide amplification appropriate for the users'
hearing losses, and that users perceive benefit from amplification consistent with
normative data. There were no serious or lasting adverse events encountered during
the study.
DO NOT OPEN HEARING AID, NO USER-SERVICEABLE PARTS INSIDE
Required Hearing Aid Information
The following additional information is provided in compliance with U.S. Food and
Drug Administration (FDA) regulations:
IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS:
Good health practice requires that a person with a hearing loss have a medical
evaluation by a licensed physician (preferably a physician who specializes in diseases
of the ear) before purchasing a hearing aid. Licensed physicians who specialize in
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