RXEARS OTC Hearing Aid Instructions
- June 13, 2024
- RXEARS
Table of Contents
RXEARS OTC Hearing Aid
Product Information
- Product Name: OTC Hearing Aid
- Manufacturer: RxEars
- Age Requirement: 18 and older
- Customer Support: Call 407-339-2422 or visit www.rxears.com
Product Usage Instructions
Age Requirement
This OTC hearing aid is only suitable for users who are 18 years old or older. If you are younger than 18 and experiencing hearing loss, it is recommended to seek specialized care from a doctor, preferably an ear-nose-throat doctor (ENT).
When to See a Doctor:
If you experience any of the following problems, it is advised to consult a
doctor, preferably an ENT:
- Your ear has a birth defect or an unusual shape.
- Your ear was injured or deformed in an accident.
- You observed blood, pus, or fluid coming out of your ear within the past 6 months.
- Your ear feels painful or uncomfortable.
- You have excessive ear wax or suspect something might be in your ear.
- You experience severe dizziness or vertigo (a feeling of spinning or swaying).
- Your hearing changed suddenly within the past 6 months.
- Your hearing fluctuates, getting worse and then better again.
- You have worse hearing in one ear.
- You hear ringing or buzzing in only one ear.
IMPORTANT GUIDANCE
Insertion Pain:
The hearing aid should not cause any pain when inserting it into your ear. If
you experience pain or discomfort, remove the device and try again following
the instructions. If the pain persists, contact the manufacturer. If the
discomfort persists, consult your hearing healthcare professional. You can
also report this to the FDA as an adverse event according to the provided
instructions.
Not Hearing Protection:
This device is not intended for use as hearing protection in loud
environments. If you encounter overly loud sounds, whether short or long-
lasting, it is recommended to remove the hearing aid. In loud places, use
appropriate hearing protection such as earplugs instead of wearing the device.
If you would use earplugs in a loud place, remove the hearing aid.
Comfortable Sound Output:
The sound output of the device should not be uncomfortably loud or painful. If
you find the sound output too loud or painful, either turn down the volume or
remove the device. If you consistently need to lower the volume, further
adjustment of the device may be necessary.
Stuck Part in Ear:
If any part of the hearing aid, such as the eartip, gets stuck in your ear and
cannot be easily removed with your fingers, seek medical help as soon as
possible. Do not attempt to use tweezers or cotton swabs, as they can push the
part farther into your ear and potentially cause serious injury to your
eardrum or ear canal.
Consult a Professional:
If you have tried the device and continue to struggle with or remain concerned
about your hearing, it is recommended to consult with a hearing healthcare
professional for further assistance and guidance.
Dear Customer,
Thank you for choosing RxEars hearing aids The FDA requires all companies
providing Over-the-counter (OTC) hearing aids to list these warnings. See 21
CFR Part 800.30 Over-the-counter hearing aid controls:
Warning: If you are younger than 18, do not use this. You should go to a doctor, preferably an ear-nose-throat doctor (an ENT), because your condition needs specialized care. Over-the- counter hearing aids are only for users who are age 18 or older
This OTC hearing aid is for users who are 18 and older. People wo are younger than 18 with hearing loss should see a doctor, preferbly an ENT, because they may need medical testing and management. Hearing loss can affect speech and learning, so professional fitting and continuing care are also important.
WARNING : When to See a Doctor
If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (An ENT).
- Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
- You saw blood, pus, or fluid coming out of your ear in the past 6 months
- Your ear feels painful or uncomfortable
- You have a lot of ear wax, or you think something could be in your ear
- You get really dizzy or have a feeling of spinning or swaying (called vertigo)
- Your hearing changed suddenly in the past 6 months
- Your hearing changes: it gets worse then gets better again You have worse hearing in one ear
- You hear ringing or buzzing in only one ear
WARNING : This hearing aid should not cuase pain when inserting it.
Remove this device from your ear if it causes pain or discomfort when you insert or place it. To try again, make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your pain or discomfort doesn’t go away, contact your hearing healthcare professional. You can also report this to fDA as an adverse event according to the instructions that appear later.
Caution : This is not hearing protection.
You should remove this device if you experience overly loud sounds, whether short or long-lasting. If you’re in a loud place, you should use the right kind of hearing protection instead of wearing this device. In general, if you would use ear plugs in a loud place, you should remove this device and use ear plugs.]
Caution : The sound output should not be uncomfortable or painful. You should turn down the volume or remove the device if the sound output is uncomfortably loud or painful. If you consistently need to turn the volume down, hyou may need to further adjust your device.
Caution : You might need medical help if a piece gets stuck in your ear.
If any part of your hearing aid, like the eartip, gets stuck in your ear, and you can’t easily remove it with your fingers, get medical help as soon as you can. You should not try to use tweezers or cotton swabls because they can push the part farther into your ear, injuring your eardrum or ear canal, possibly seriously.
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 may 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 getmore 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, 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. Instructions for reporting are avaialbe at https://www.fda.gov/Safety/ MedWatch, or call 1-800-FDA-1088. You can also download a form to mail to FDA
Article No: UG_rx_fdawarninside_11_22_rev- ©
References
Read User Manual Online (PDF format)
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