ATLAS OTC Hearing Aids
Frequently Asked Questions

1. What is an OTC hearing aid?

OTC hearing aids are FDA-regulated devices designed for adults (18+) with perceived mild-moderate hearing loss. They can be purchased directly by consumers without a prescription, hearing exam, or audiologist fitting.

 

2. Who is a good candidate for an OTC hearing aid?

OTC hearing aids are for adults 18 and over who are experiencing mild-moderate hearing difficulties, such as feeling tired trying to hear, trouble following conversations in noisy environments or needing the TV volume higher than others prefer. Those with severe hearing loss should consult a hearing professional.

 

3. Do I need a hearing test before making a purchase?

No. FDA has provided a list of signs for self-detection, without an audiogram. However, a hearing test is recommended if you are unsure about the degree of your hearing loss.

 

4. Are there FDA Standards for OTC hearing aids?

Yes, all OTC hearing aids must comply with FDA standards regarding performance, safety, labeling for safe and effective use. These are detailed in the OTC Final Rule and 21CFR800.30. These devices also need to be designed, manufactured and tested following the FDA's Quality System Regulation to make sure that each hearing aid meets the OTC standards. 

 

5. What support is available after purchase?

Audition Technology offers the ATLAS OTC Program to support users, that include:

• ATLAS OTC Hearing Aids and Accessories: For self-detected mild-moderate hearing loss.

• ATLAS eCoach: A personal guide to hearing success. Enjoy easy, step-by-step guides for using and caring for your hearing aids, improving daily wear and communication, supporting your overall well-being, and tracking your hearing recovery and Quality of Life. A great way to stay connected with your care partner. Developed with current federal and state guidances, this original program is protected by copyright. 

• ATLAS Safe Listen Tools: Resources to protect against unsafe noise levels to maintain your current natural hearing, promote hearing health.

• ATLAS Earcare Tools: Protect your ear health with the Safe Listen eTool and reusable earplugs. Learn to recognize everyday 'loud' sounds, other risks that can worsen noise harm and how to protect your remaining hearing. The earplugs have been tested per EPA standards. The eTool is unique and has been granted copyright protection. In addition, earwax remover drops and otoscope ae available to support OTC hearing aid use such as manage earwax common with hearing aid use, identify FDA's 'Red Flags' in a timely manner to get medical help, check for stuck eartips and know how to safely remove. Accompanying guide cards provide directions specific to OTC hearing aid use. Available for separate purchase from ATLAS Store.

• ATLAS OTC Store: One-stop shop for OTC hearing aid accessories, earcare products.

• Customer Support: For direct assistance, you can contact Audition Technology at 1-844-576-1110 or email contact@auditiontech.com.

6. How do I adjust the settings on my OTC hearing aid?

ATLAS OTC hearing aids include adjustable volume and sound presets. There are voice prompts that make it easy to adjust the settings while you are wearing the hearing aids.

 

7. What should I do if the hearing aid doesn’t seem to work properly?

Consult the user manual for correct use and troubleshooting steps, refer to the ePortal for additional guidance. Remember that it will take a little time to get used to wearing and listening to the new sounds of the hearing aid. Step-by-step guidance is provided in the ePortal. If issues persist, contact our customer service team for support. 

 

8. How do I clean and maintain my hearing aid?

Daily wiping down of hearing aid, eartubes and eartips, and storing in a clean, open space (when removed at night) are important for proper functioning. Do not use water or any cleaning solutions. Replace accessories every 3 months or when they are dirty.  See the user guide for full maintenance instructions.

It is also important to clean earwax regularly and check for 'Red Flags' to have a healthy earcanal. Refer to the earcare products available on ATALS Store.

 

9. Will insurance cover OTC hearing aids?

Currently, most insurance plans, including Medicare, do not cover OTC hearing aids. ATLAS OTC Hearing aids meet the requirements to be HSA/FSA-eligible medical devices for reimbursement under many plans. Please check with your plan administrator.