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You can also report this to the FDA as an adverse event. To do this,
please follow the instructions that will appear later in this manual.
4. WARNING: Do Not Use This Product If Any of the Following Apply
To You
• Congenital atresia of external ear or deformity of any part of the ear
canal
• Deafness is unstab le, and the degree of hearing loss often
fluctuates
• Persistent headaches, dizziness, earaches, tinnitus or other
symptoms that are not suitable for adaptation
• Sudden onset of hearing loss within the past 3 months; rapid
progressive deafness; unilateral hearing loss or other acute ear
disease
• Effusion (secretions/discharge) in the ear and/or frequent purulence
(pus).
• Central deafness (central nervous system) or non-organic
deafness.
• Patients with acute otitis externa and tympanitis.
• Patients with acute and chronic suppurative otitis media
(in the period of purulent infection).
• Patients who are allergic to the materials of this product.
5. WARNING: Important Safety Instruction
• Keep small parts (hearing instrument(s), ear tips, battery or other
detachable parts) that can be swallowed out of reach of children.
• Dropping, immersing in liquid, exposure to strong electromagnetic
fields and/or excessive heat will damage the hearing aid. Remove
devices prior to any type of X-ray, MRI, or CT scan.
• If parts become stuck in the ear canal, seek medical assistance. Do
not attempt to remove the device by yourself.
• Do not use at high volume for extended periods of time. Ear injury
can result.
• If you experience any pain or strong discomfort using the devices,
remove them immediately and consult a doctor.
• Routine maintenance to keep the device clean is required. Ensure
that the ear tips are free of debris and moisture at all times.
• Do not store or use the product in environments of high humidity or
temperature (such as a sauna or steam room), to avoid damage.
• Batteries should be properly recycled and not disposed of in the
trash.
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