Over-the-counter (OTC) hearing aids are devices that are designed to help people with mild to moderate hearing loss. Unlike traditional hearing aids, which require a prescription and fitting from a hearing healthcare professional, OTC hearing aids can be purchased directly by the consumer without the need for a prescription or fitting.

The regulation of OTC hearing aids by the FDA (U.S. Food and Drug Administration) is designed to ensure that these devices are safe and effective for their intended use. In 2017, the FDA announced a commitment to create a new regulatory category for OTC hearing aids to increase accessibility and affordability for individuals with mild to moderate hearing loss.

Here's an overview of how OTC hearing aids are regulated:

FDA Clearance: OTC hearing aids must receive clearance from the FDA before they can be marketed and sold to consumers. This process involves demonstrating that the device meets certain safety and efficacy standards.

Regulatory Controls: The FDA has established regulatory controls for OTC hearing aids to ensure their safety and effectiveness. These controls include requirements related to labeling, performance standards, and manufacturing practices.

Labeling Requirements: OTC hearing aids must include certain labeling information, such as a statement indicating that the device is intended for use by individuals with mild to moderate hearing loss and a warning to consult with a healthcare professional before use.

Performance Standards: OTC hearing aids must meet certain
performance standards to ensure that they provide appropriate amplification and
sound quality for individuals with mild to moderate hearing loss.

Post-Market Surveillance: The FDA monitors the safety and effectiveness of OTC hearing aids through post-market surveillance activities, such as adverse event reporting and compliance monitoring. Overall, the FDA's regulatory oversight of OTC hearing aids is intended to ensure that these devices are safe, effective, and suitable for use by individuals with mild to moderate hearing loss.

There are several reasons why OTC hearing aids are generally cheaper than traditional hearing aids:

Regulatory Requirements: OTC hearing aids are subject to different regulatory requirements than traditional hearing aids. The FDA has streamlined the regulatory process for OTC hearing aids to make them more accessible and affordable. This can reduce the cost of bringing these devices to market, which can translate into lower prices for consumers.

Distribution Model: OTC hearing aids are typically sold directly to consumers, often through retail channels or online stores. This eliminates the need for the involvement of a healthcare professional, such as an audiologist or hearing aid dispenser,
which can reduce costs.

Technology: OTC hearing aids may use simpler technology
than traditional hearing aids, which can lower manufacturing costs. While they are still designed to provide amplification and improve hearing, they may not have the advanced features and customization options that are available in traditional hearing aids.

Fitting and Follow-up Services: Traditional hearing aids often require fitting and follow-up services from a healthcare professional, which can add to the overall cost. OTC hearing aids are designed to be self-fitted, which can reduce the need for these additional services.

OTC hearing aids are not typically covered by insurance, whereas traditional hearing aids may be covered partially or fully by insurance plans.

OTC hearing aids are designed to provide amplification and improve hearing for individuals with mild to moderate hearing loss. They are intended to help people hear better in various situations, such as during conversations, while watching TV, or when listening to music. If you have more severe hearing loss or other underlying medical conditions affecting your hearing, it's advisable to consult with a hearing healthcare professional to determine the best course of action for your hearing health.

Yes, it can take time to get used to hearing aids. When you first start wearing
hearing aids, your brain needs time to adjust to the new sounds and the way they are amplified.

Here are some common experiences that people may have when they start wearing hearing aids:

Initial discomfort: Some people may experience initial discomfort or even mild pain when they start wearing hearing aids. This can be due to the physical sensation of having something in your ear or the sound of your own voice being amplified.

Sound quality: The sound quality of hearing aids may initially seem different from what you are used to. Sounds may seem too loud or too sharp, and you may notice background noises more than before.

Adjustment period: It can take time for your brain to adjust to the new sounds provided by the hearing aids. During this adjustment period, you may need to gradually increase the amount of time you wear your hearing aids each day.

Speech understanding: Hearing aids can improve your ability to hear speech, but it may take time to get used to understanding speech in different environments, such as in noisy or crowded places.

Maintenance and care: Learning how to properly clean and maintain your hearing aids is important for ensuring their effectiveness and longevity. This may require some time and practice.

Yes, we have U.S. based customer support. We answer emails within 24 hours at support@clarityproducts.com.You can also call us at 800-426-3738.

If we are busy or unavailable, please leave a message and we’ll call you back as soon as possible.

All hearing aids can suffer from feedback as the microphone and speakers are in close proximity. Try turning down the volume and adjusting the hearing aid. Once the hearing aid is properly positioned over the ear it should not be suffering feedback.

Try putting the hearing aids back in the case. When you take them out after a few seconds this will restart the pairing process. Please see the instruction manual and the video on this website about the subject.

Yes, the app makes the hearing aids easier to adjust but the hearing aids have a volume button and will function without the need for the app.

The HS LOC is your handset locator button so you will look for a button on your base that says either “PAGE” or “FIND.”

Try to reset the phone, which will be like rebooting a computer.  To do that, you will unplug the power cord (if applicable) and the phone line cord from the base and take the batteries out of the base and handset (if applicable) and leave for thirty minutes.  After thirty minutes, plug it back in and put the batteries back in and see if that helps.  If not, please contact support.

Please contact customer support for information about your state.