Hearing loss affects 30 million adults in the US, with a high number of people affected by it. Only one-fifth of those who could benefit from a hearing aid seek intervention. To increase access to hearing aids, the FDA Approval for OTC hearing aids for adults 18–20 with perceived mild to moderate hearing loss.
Over-the-Counter Hearing Aids
A hearing aid is a medical device designed to help with hearing loss, worn behind or within the ear canal, and regulated by the FDA to ensure safety and effectiveness.
- Air-conduction hearing aids are without surgical intervention and bring amplified sound into the ear canal. The sound then moves through the eardrum and three tiny bones in the middle ear, where it is processed and sent to the brain.
- People 18-20 are used to help with mild to moderate hearing loss.
- Allow users to customize a device to their hearing needs through tools, tests, or software.
- Wireless technology may be used to assess hearing loss through self-assessment tests.
Who can buy an OTC hearing aid?
- If you are 18 years or older the OTC hearing aid can be purchased in a store or online without an ENT doctor or licensed hearing health care professional.
- Younger people need to get hearing aids by prescription and seek specialized care if they are younger than 18.
Where to Purchase OTC Hearing Aids
- OTC hearing aids can be bought in person or through online retailers without the need for a medical exam, prescription, or fitting adjustment.
- OTC hearing aids can be bought from a hearing healthcare professional who can perform a hearing test and evaluation.
Wearing hearing aids can help you become accustomed to their features and modify the program settings for various listening situations. Regular practice is necessary to practice putting on and taking off your hearing aids.
Report Problems to FDA
Use the online MedWatch form or contact the FDA by phone at 1-800-FDA-1088 to report any injuries, malfunctions, or other adverse events associated with medical devices, including over-the-counter hearing aids. Send the data to the FDA as soon as you can following the incident. Injuries from the device (such as cuts, scrapes, or burns from an overheated battery), device fragments stuck in your ear canal, or a rapid worsening of your hearing loss with device use are a few examples of adverse effects.
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Source:FDA.gov
