In the United States, nearly 30 million adults experience some level of hearing loss. Surprisingly, only about one-fifth of those who could benefit from a hearing aid actually seek help. By using hearing aids, individuals can potentially reduce the frequency and severity of cognitive decline, depression, and other health issues.
Additionally, these devices can lead to improved social participation and an enhanced quality of life. Recognizing the need to enhance accessibility, the FDA introduced a new category of over-the-counter (OTC) hearing aids for adults aged 18 and older with perceived mild to moderate hearing loss. This change came into effect on October 17, 2022.
Understanding Over-the-Counter OTC Hearing Aids
OTC hearing aids are medical devices designed to assist with hearing loss and are worn either behind or within the ear canal. To ensure consumer safety and effectiveness, the FDA regulates all types of hearing aids.
Here are some key features of OTC hearing aids:
- Air-conduction hearing aids: These aids amplify sound and do not require surgical implantation or other invasive procedures. Sound travels through the ear canal, reaching the inner ear where it is processed and sent to the brain via the eardrum and the three small bones in the middle ear.
- Target audience: OTC hearing aids are intended for adults aged 18 and older who experience perceived mild to moderate hearing loss.
- Customizable settings: Users have control over the device settings, allowing them to tailor the device to their specific hearing needs. This can be achieved through the use of tools, tests, or software.
- Wireless technology and self-assessment: OTC hearing aids may incorporate wireless technology and offer self-assessment tests to help users evaluate their hearing loss.
- Accessibility: OTC hearing aids are available without the involvement or prescription of a licensed healthcare professional. Consumers can purchase these devices online or from physical stores, as long as they meet the FDA’s requirements.
Device Options within the OTC Hearing Aid Category
Within the OTC hearing aid category, individuals aged 18 and older experiencing perceived mild to moderate hearing loss have several device options available to them:
- Legacy and wireless hearing aids: These devices provide basic features like volume control and preset programs.
- Self-fitting hearing aids: These aids offer greater customization through advanced technology, such as hearing tests, software, and smartphone applications. Some may also include wireless features.
It’s important to note that prescription hearing aids refer to devices that are not classified as OTC hearing aids. They can only be obtained through a licensed hearing healthcare professional who can customize the device based on individual hearing loss. Prescription hearing aids are suitable for all levels of hearing loss and all age groups, as determined by their specific indications for use.
Before Purchasing an OTC Hearing Aid: What You Need to Know
Who Can Purchase an OTC Hearing Aid?
If you are 18 years of age or older and believe you have perceived mild to moderate hearing loss, you can purchase an OTC hearing aid from a store or online without the need to consult an ear-nose-throat (ENT) doctor or a licensed hearing healthcare professional (audiologist).
However, it’s important to remember that OTC hearing aids are only suitable for perceived mild to moderate hearing loss and not for the treatment of severe or profound hearing loss.
If you suspect you have more severe hearing loss, it is advisable to consult with a licensed hearing healthcare professional, as OTC hearing aids may not provide sufficient benefit in such cases.
Individuals younger than 18 years of age must obtain their hearing aids through a prescription and seek specialized care from a doctor, preferably an ENT.
Where Can You Purchase an OTC Hearing Aid?
OTC hearing aids are available for purchase in physical stores or through online retailers. They can be obtained without the need for a medical examination, prescription, or fitting adjustment by an audiologist.
It is recommended that you review the labeling on the external packaging before purchasing an OTC hearing aid. If the packaging information is not readily available, please reach out to the seller or manufacturer.
The OTC hearing aid regulation requires important information to be displayed on the packaging, allowing consumers to make informed decisions before purchasing.
OTC Hearing Aid – External Packaging Information
The FDA regulations mandate that specific information be included on the external packaging of OTC hearing aids. Carefully examine the packaging for the following details:
- Warnings and additional information about hearing health, including the prohibition of use by individuals younger than 18 years of age.
- Symptoms indicating perceived mild to moderate hearing loss, help you determine if you may benefit from an OTC hearing aid.
- Advice on when to seek healthcare services, particularly for those experiencing more severe hearing difficulties or associated symptoms.
- “Red flag” conditions that require immediate medical attention, such as ear abnormalities, recent ear-related issues, pain, excessive earwax, dizziness, sudden hearing changes, or ringing in one ear.
- Contact information for further inquiries or obtaining additional labeling and resources.
- Manufacturer’s return policy, indicating the terms of return or warranty.
- The clear display of the words “OTC” and “hearing aid” on the packaging.
- Information about the type and quantity of batteries, and whether batteries are included.
- Whether a mobile phone or remote-control device is required to operate the OTC hearing aid.
It’s essential to note that claims such as “FDA Registered” or “FDA Certified” on OTC hearing aid packaging can be misleading. For accurate information on FDA-approved devices, please refer to the relevant guidelines and policies.
Furthermore, while OTC hearing aid regulations do not mandate manufacturers to provide warranties, it is crucial to understand the terms of any applicable return or warranty period. This allows sufficient time for testing the device in different environments and adapting to new sounds.
After Purchasing an OTC Hearing Aid: What You Need to Know
It takes time and practice to adjust to wearing hearing aids. Consistent usage and familiarity with the device’s features are essential. You may need to practice inserting and removing the hearing aids, as well as learn how to adjust program settings for different listening environments.
If you feel that you are not experiencing the expected benefits from your OTC hearing aids, consider seeking a consultation with a hearing healthcare professional.
Reporting Issues with OTC Hearing Aids to the FDA
If you encounter any injuries, malfunctions, or adverse events related to medical devices, including OTC hearing aids, it is important to report them to the FDA. You can submit information through the online MedWatch form or by calling 1-800-FDA-1088 as soon as possible following the event.
Adverse events may include irritation of the ear canal or outer ear skin, injuries caused by the device, such as cuts, scratches, or burns from overheated batteries, device fragments lodged in the ear canal, or sudden worsening of hearing loss associated with device use.
Reporting Allegations of Regulatory Misconduct
Reporting allegations of regulatory misconduct can help the FDA identify potential violations and assess risks to patients. If you suspect a medical device manufacturer or individuals marketing OTC hearing aids are violating regulations, you can submit information through the Reporting Allegations of Regulatory Misconduct platform. This information assists the FDA in determining the need for further investigation and implementing corrective measures, if necessary.
