We're sure you've heard about the recent FDA approval for OTC (Over The Counter) hearing aids.
Leading up to the approval there has been misinformation and false marketing practices. The use of a single term in advertising can mislead you into thinking the product is FDA approved. HLAA has been involved every step of the way and has helped determine the regulations that were approved.
HLAA is concerned that consumers might purchase Personal Sound Amplification Products (PSAPs) instead of traditional hearing aids, assuming these devices are legitimate OTC hearing aids. PSAPs are amplification devices available now that are intended only for those with normal hearing who want to amplify sounds. PSAPs are not interchangeable with hearing aids, are not intended to compensate for or treat hearing loss, and do not provide the sound filtering that an FDA-approved hearing aid does. The FDA prohibits manufacturers of PSAPs from marketing their products as hearing aids to people with hearing loss.
Another fact:
OTC hearing aids are designed for adults with mild to moderate hearing loss only.
How Do I Know What Is FDA Approved?
Look for hearing aid products that say they are:
FDA Approved
FDA Cleared
FDA Authorized
The FDA does not use these terms.
These terms may be used to mislead you:
FDA Registered
FDA Certified
FDA Registration Certificate
Considering OTC Hearing Aids?...
Click on these links to gather information:
HLAA’s OTC Tip Sheet Can Help
HLAA in the News
Find all the latest articles here:
OTC hearing aid articles gathered by HLAA
Opinion:
FDA's new hearing aid rules help some but leave others behind
OTC Hearing Aids:
Returns – a key piece of the puzzle
HLAA OTC Hearing Aids multiple links:
https://www.hearingloss.org/hearing-help/technology/otc-hearing-devices/
FDA issued final rules:
Establishing OTC Hearing Aids
FDA Complaint MedWatch:
How to file a complaint
Leading up to the approval there has been misinformation and false marketing practices. The use of a single term in advertising can mislead you into thinking the product is FDA approved. HLAA has been involved every step of the way and has helped determine the regulations that were approved.
HLAA is concerned that consumers might purchase Personal Sound Amplification Products (PSAPs) instead of traditional hearing aids, assuming these devices are legitimate OTC hearing aids. PSAPs are amplification devices available now that are intended only for those with normal hearing who want to amplify sounds. PSAPs are not interchangeable with hearing aids, are not intended to compensate for or treat hearing loss, and do not provide the sound filtering that an FDA-approved hearing aid does. The FDA prohibits manufacturers of PSAPs from marketing their products as hearing aids to people with hearing loss.
Another fact:
OTC hearing aids are designed for adults with mild to moderate hearing loss only.
How Do I Know What Is FDA Approved?
Look for hearing aid products that say they are:
FDA Approved
FDA Cleared
FDA Authorized
The FDA does not use these terms.
These terms may be used to mislead you:
FDA Registered
FDA Certified
FDA Registration Certificate
Considering OTC Hearing Aids?...
Click on these links to gather information:
HLAA’s OTC Tip Sheet Can Help
HLAA in the News
Find all the latest articles here:
OTC hearing aid articles gathered by HLAA
Opinion:
FDA's new hearing aid rules help some but leave others behind
OTC Hearing Aids:
Returns – a key piece of the puzzle
HLAA OTC Hearing Aids multiple links:
https://www.hearingloss.org/hearing-help/technology/otc-hearing-devices/
FDA issued final rules:
Establishing OTC Hearing Aids
FDA Complaint MedWatch:
How to file a complaint