Earlens Contact Hearing Solution User Manual page 6

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What you might expect when you start using a hearing aid. A hearing aid can benefit many
people with hearing loss. However, you should know it will not restore normal hearing, and
you may still have some difficulty hearing over noise. Further, a hearing aid will not prevent or
improve a medical condition that causes hearing loss. People who start using hearing aids
sometimes need a few weeks to get used to them. Similarly, many people find that training or
counseling can help them get more out of their devices. If you have hearing loss in both ears,
you might get more out of using hearing aids in both, especially in situations that make you
tired from listening — for example, noisy environments.
Tell FDA about injuries, malfunctions, or other adverse events. To report a problem involving
your hearing aid, you should submit information to FDA as soon as possible after the problem.
FDA calls them "adverse events," and they might include: skin irritation in your ear, injury from
the device (like cuts or scratches, or burns from an overheated battery), pieces of the device
getting stuck in your ear, suddenly worsening hearing loss from using the device, etc.
8
Notices
Instructions for reporting are available at https://www.fda.gov/Safety/MedWatch, or call
1-800-FDA-1088. You can also download a form to mail to FDA.
9

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