OTOFONIX HELIX User Manual page 5

Notes
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Note: If you remain concerned, consult a professional.
If you try this device and continue to struggle with or remain concerned about your hearing, you
should consult with a hearing healthcare professional.
Note: 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.
Note: Tell FDA about injuries, malfunction, 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 overheated battery), pieces of the
device getting stuck in your ear, suddenly worsening hearing loss from using the device etc.
Instructions for reporting are available at https://fda.gov/Safety/MedWatch, or call 1-800-FDA-1088.
You can also download a form to mail to FDA.
Please call Otofonix Hearing Solutions at (704)380-0508 if you have any questions or concerns.