Important Safety Information

OTCHealth Inc. is committed to your hearing health and safety. Please read the following information before purchasing or using any hearing product sold on OTCHealthMart.com. This information is provided in accordance with the U.S. Food and Drug Administration (FDA) Over-the-Counter Hearing Aid Rule (21 CFR 800.30).

For adults 18 and older

Over-the-counter (OTC) hearing aids are intended for use by adults age 18 and older who have perceived mild to moderate hearing difficulty. They are not intended for children. If you are under 18, or are purchasing for someone under 18, do not use an OTC hearing aid. Consult a licensed physician, preferably an ear, nose and throat (ENT) doctor, who can identify and treat causes of hearing loss in children.

Signs you may have mild to moderate hearing loss

You may benefit from a hearing aid if you notice that you:

Have trouble hearing conversations in noisy places such as restaurants or groups
Often ask people to repeat themselves
Turn up the volume on the TV or phone higher than others prefer
Have difficulty hearing on the telephone
Feel that people seem to mumble or speak unclearly

If you have more than mild to moderate difficulty, or your hearing loss is severe, see a hearing healthcare professional.

See a doctor before use: "Red flag" conditions

Consult a licensed physician, preferably an ENT doctor, before using an OTC hearing aid if any of the following apply to you:

A birth defect or unusual shape of the ear, or an ear that was injured or deformed in an accident
Blood, pus, or fluid coming from the ear within the past 6 months
Hearing loss that came on suddenly, worsened rapidly, or comes and goes within the past 6 months
Dizziness or a sensation of spinning (vertigo)
Hearing loss in only one ear, or a noticeable difference in hearing between your ears
Pain or discomfort in the ear
A buildup of ear wax, or a feeling that something is in your ear canal
Ringing (tinnitus) in only one ear, or much worse in one ear than the other

These signs can indicate a condition that should be evaluated by a medical professional.

Using your hearing aid safely

Follow the instructions included with your device. Set the volume to a comfortable level and avoid prolonged exposure to loud sound. Insert eartips only as directed and never past the depth indicated, to protect your eardrum. Keep devices, batteries, and small parts away from children and pets, as they can be a choking hazard. If a part becomes lodged in your ear, or you experience pain, irritation, or sudden changes in hearing, stop use and contact a healthcare professional.

Personal Sound Amplification Products (PSAPs)

Some products sold on OTCHealthMart.com are Personal Sound Amplification Products (PSAPs). PSAPs are consumer electronic products that amplify sound in certain situations, such as recreational listening. PSAPs are not hearing aids, are not intended to treat hearing loss, and are not regulated by the FDA as medical devices. Product listings clearly identify which items are OTC hearing aids and which are PSAPs.

About our telehealth services

Telehealth consultations offered through OTCHealth are provided by independently licensed healthcare professionals. These services are intended to support your care and provide general guidance. They do not replace an in-person examination, diagnosis, or treatment by your own physician. In an emergency, call 911 or seek immediate in-person medical care.

Reporting a problem to the FDA

If you experience a side effect, injury, or other problem with a hearing aid, you are encouraged to report it to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/medwatch
By phone: 1-800-FDA-1088 (1-800-332-1088)

Please also contact us so we can assist you directly.

Returns

Return policies for each product are described on the product page and in the materials included with your device. Please review the applicable return policy before purchase.

Contact us

We are here to help with questions, support, and product information.

Email: care@otchealthmart.com
Phone: (800) 864-4337
Mailing address: available upon request by email or phone

OTCHealth Inc., OTCHealthMart.com