HEARVELAOTC hearing aid information
HEARVELA hearing aids are over-the-counter (OTC) hearing aids. This page summarizes important information. Always read the user guide and label that come with your device. [VERIFY: replace with the exact FDA-required label text for the cleared/listed model.]
Intended use
For adults 18 years of age and older with perceived mild to moderate hearing loss. Not intended for children or for severe or profound hearing loss.
Who OTC hearing aids are (and aren't) for
OTC hearing aids are intended for adults 18 and older with perceived mild to moderate hearing loss. They are not intended for severe or profound hearing loss, and they are not for children.
See a doctor, preferably an ear specialist, before using a hearing aid if you have:
- A visible deformity of the ear, from birth or injury
- Fluid, pus or blood coming out of the ear in the past 6 months
- Pain or discomfort in the ear
- A history of excessive earwax, or you suspect something is in your ear canal
- Episodes of vertigo or severe dizziness
- Sudden, quickly worsening or fluctuating hearing loss in the past 6 months
- Hearing loss or ringing (tinnitus) in only one ear, or a noticeable difference between ears
Sudden hearing loss can be a medical emergency. If you notice it, contact a doctor right away. A hearing aid will not restore normal hearing or prevent hearing loss. Read the full OTC hearing aid information.
Important information
- A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions.
- Stop using the device and see a doctor if you feel pain or discomfort in your ear, or if the device causes skin irritation or makes you dizzy.
- If the device gets stuck in your ear, see a doctor. Do not try to remove it with tools.
- Using a hearing aid is only part of hearing health. You may benefit from a hearing test by a hearing professional.
- Keep devices and small parts away from children and pets. Batteries and small parts can be dangerous if swallowed.
Questions
Email [email protected].