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ATLAS OTC-Hear

User Instructional Brochure

For Mild-Moderate Hearing Loss

 

  • Trouble hearing in noisy places, over the phone

  • Hard to follow speech in groups

  • Feeling tired trying to listen

  • Turning up the volume and others complain

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 18 years and older. People who are younger than 18 with hearing loss should see a doctor, preferably an ENT, because they may need medical testing ad management. Hearing  loss can affect speech and learning, so professional fitting and hearing care are also important.

WARNING: When to see a doctor

If you have any of these problems listed below, please see a doctor, preferable an ENT. You have the option of consulting with an Audiologist, through Audiology Connect, prior to seeing a doctor.

  • Yue 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 earwax, 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 cause pain when inserting it

Remove this hearing aid 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 us. If you pain or discomfort does not go away, contact us. You have the option of consulting with an Audiologist, through Audiology Connect by Evolve.  You can also report this to FDA as an adverse event according to the instructions that appear later.

Note: Read the full manual to understand safe and correct use of your ATLAS OTC hearing aid. 

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, you would use plugs in a loud place, you should remove this device and wear hearing plugs. 

Note: Plugs with use instructions are included in your ATLAS OTC kit for your hearing protection.

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 down the volume, you 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 have the option of consulting with an Audiologist through Audiology Connect by Evolve.. You should not try to use tweezers or cotton swabs as they can push the part farther into your ear, injuring your ear drum 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 professional. You have a the option of consulting with an Audiologist through Audiology Connect by Evolve.. 

Note: What you might expect when you start using your hearing aid

A hearing aid can benefit many people with hearing loss. However, you should know it will not restore normal hearing, 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 the 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 on 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://www.fda.gov/Safety/ MedWatch, or call 1-800-FDA-1088. You can also download form to mail to FDA.

Also contact us for reporting these problems. ....................................DETAILS............

Sections

Know your ATLAS OTC-Hear 

illustration(s), operating controls, user adjustments, battery compartment, function of all controls  for user adjustment

Specifications

Electrical, EMC safety

No wireless

Sizing and inserting the eartip

of the OTC hearing aid to prevent insertion past the depth limit and damage to the tympanic membrane.

Battery 

battery is replaceable or how to replace 

subscritpion service opotion, Expected battery life.

Know your ATLAS OTC Kit

A description of any accessory that accompanies the OTC hearing aid, including but not limited to wax guards and accessories for use with a computer, television, or telephone.

ADD: CaptionCall

Using OTC kit components 

of the OTC hearing aid to prevent insertion past the depth limit and damage to the tympanic membrane.

Damage prevention

commonly occurring, avoidable events that could damage, including , ear wax buildup, drops, immersion in water, or exposure to excessive heat.

Setting up and using your OTC  hearing aid

of the OTC hearing aid to prevent insertion past the depth limit and damage to the tympanic membrane.

Use with phone

other use conditions

Maintenance and care 

clean, disinfect, and replace parts or how to seek replacements, as well as how to store the hearing aid 

Returns, Repair, Replacements

ow and where to obtain repair service or replacements, including at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service or replacements.

Section Title

erformance of the OTC hearing aid, a summary of all such studies.

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