What are the signs and symptoms of hearing loss?

You may have a hearing loss if:

• people say you are shouting when you talk to them
• you need the TV or radio turned up louder than other people
• you often ask people to repeat themselves because you can't hear or understand them, especially in groups or when there is background noise
• you can hear better out of one ear than the other
• you have to strain to hear
• you can't hear a dripping faucet or a high pitched note of a violin
• you think people 'mumble' when they speak
• If you have any of these signs and symptoms, you should consider seeing your doctor or hearing healthcare professional to be tested for hearing loss.

What are the different types of hearing loss?

• Sensorineural - a hearing loss that usually develops due to damage to the small sensory cells in the inner ear, called hair cells. This damage can occur as a result of disease, illness, age, injury from exposure to noise or certain medicines, or as the result of a genetic disorder.
• Conductive - a hearing loss that occurs when sound waves cannot transmit through the outer or middle ear or both. This can, for example, be caused by earwax, fluid in the middle ear space, or a punctured eardrum. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss.
• Mixed - a combination of sensorineural and conductive hearing loss.

Only a relatively small portion of adult hearing problems, such as ear infection and middle ear diseases, are medically or surgically treatable. If the condition cannot be treated medically or surgically, hearing aids may be beneficial.

Over-the-counter (OTC) hearing aids are a new category of hearing aids that consumers can buy directly, without visiting a hearing health professional. These devices are intended to help adults with perceived mild to moderate hearing loss. Like prescription hearing aids, OTC hearing aids make sounds louder so that some adults with difficulty hearing are better able to listen, communicate, and participate fully in daily activities. In addition, OTC hearing aids are regulated as medical devices by the U.S. Food and Drug Administration (FDA).

OTC hearing aids are an alternative to prescription hearing aids, which are currently only available from hearing health professionals, such as audiologists, otolaryngologists (ear, nose, and throat doctors), and hearing aid specialists. The hearing health professional fits you for the hearing aid, adjusts the device based on your hearing loss, and provides other services.

You can buy OTC hearing aids as soon as mid-October 2022 directly in stores and online, where prescription hearing aids are not available. You fit them yourself, and you may be able to control and adjust the devices in ways that users of prescription hearing aids cannot. Some OTC hearing aids might not look like prescription hearing aids at all.

OTC hearing aids are for adults with perceived mild to moderate hearing loss. They are not meant for children or for adults who have more severe hearing loss or significant difficulty hearing. If you have more severe hearing loss, OTC hearing aids might not be able to amplify sounds at high enough levels to help you.

The FDA has established regulations that manufacturers of OTC hearing aids need to follow. In general, these federal regulations:

• Ensure that the OTC devices are safe and effective for people with perceived mild to moderate hearing loss.
• Set standards for package labels to help buyers understand OTC hearing aids and who might benefit from them. The labels also include warnings and other information you should know before buying or when using the hearing aid, such as signs that indicate that you should see a doctor.

Personal sound amplification products (PSAPs) are another class of amplifying devices that you can purchase without a prescription or seeing a health care professional. PSAPs are for people without hearing loss. They boost the ability to hear certain sounds in specific situations, such as while bird-watching. While the FDA regulates OTC hearing aids as medical devices for adults for hearing loss, PSAPs are not regulated as medical devices by the FDA.

OTC hearing aids are for adults (18 and older) who believe they have mild to moderate hearing loss, even if they have not had a hearing exam. You might have mild to moderate hearing loss if, for example:

• Speech or other sounds seem muffled.
• You have trouble hearing when you’re in a group, in a noisy area, on the phone, or when you can’t see who is talking.
• You have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
• You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

If you have trouble hearing conversations in quiet settings—or have trouble hearing loud sounds, such as cars or trucks, noisy appliances, or loud music—consult a hearing health professional. These are signs that you might have more severe hearing loss and that OTC hearing aids won’t work well for you. A hearing health professional can help you determine if a prescription hearing aid or other device can help you hear better.

Some ear problems need medical treatment. If you have any of the following, please see a licensed physician promptly:

• Fluid, pus, or blood coming out of your ear within the previous 6 months.
• Pain or discomfort in your ear.
• A history of excessive ear wax or suspicion that something is in your ear canal.
• Episodes of vertigo (severe dizziness) with hearing loss.
• Sudden hearing loss or quickly worsening hearing loss.
• Hearing loss that has gotten more and then less severe within the last 6 months.
• Hearing loss or tinnitus (ringing) in only one ear, or a noticeable difference in how well you can hear in each ear.

Hearing loss significantly affects quality of life for tens of millions of adults in the United States and contributes to high health care costs. Untreated hearing loss can lead to isolation, and it has been associated with serious conditions such as depression, anxiety, low self-esteem, dementia, reduced mobility, and falls. Yet only one in four adults who could benefit from hearing aids has ever used them. Making hearing health care more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. continues to grow.

Leading experts in science, technology, and hearing health care have been working with researchers, health professionals, and consumers to find safe and effective ways to improve access to hearing health care for adults. They suggested changing some regulations that studies showed were barriers to adults getting the hearing help they need. They also recommended that the FDA create guidelines and quality standards for OTC hearing aids.

A law established as part of the FDA Reauthorization Act of 2017 directed the FDA to create a category of OTC hearing aids for adults with perceived mild to moderate hearing loss. As part of this process, in October 2021, the FDA formally proposed a rule to establish the new OTC hearing aids category. Finalized in August 2022, the final rule allows hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. Hearing aids for more severe hearing loss or for users younger than age 18 remain prescription devices.

How do I get hearing aids?

Before getting a hearing aid, you should consider having a hearing evaluation to determine the type and amount of your hearing loss. The process can begin with a medical and/or audiological examination.

• Medical examination. The medical examination may be performed by any licensed physician including your family doctor or pediatrician, but preferably should be done by an ear, nose, and throat specialist (an otolaryngologist). An examination of your ear, nose, and throat and possibly other testing can be done to rule out any medical reason for your hearing loss, such as infection, injury or deformity, ear wax in the ear canal, and, in rare cases, tumors.
• Audiological examination. An audiological exam, or audiogram, involves a hearing evaluation by a hearing health professional that specializes in evaluation, non-medical treatment, and rehabilitation of hearing loss (an audiologist) to identify the type and amount of your hearing loss, to determine the need for medical/surgical treatment and/or referral to a licensed physician, and to provide rehabilitation of the hearing loss.

What if I don't want to have a medical examination?

The FDA believes that, in some instances, it could be in your best health interest to have a medical examination by a licensed physician—preferably one that specializes in ear diseases—before buying hearing aids. However, for consumers 18 years of age and older, the FDA does not intend to enforce the requirement for a medical examination prior to purchasing certain types of hearing aids. For hearing aid consumers younger than 18 years of age, the FDA will continue to enforce the medical evaluation requirement to rule out medical causes of hearing loss prior to buying hearing aids.

Where should I go to get hearing aids?

Typically, hearing aids are sold by a hearing health care professional (for example, an audiologist or a hearing aid dispenser), who can perform a hearing assessment and hearing aid evaluation. If you have concerns about a medical condition causing your hearing loss, we recommend that you have a medical evaluation by a licensed physician (preferably one who specializes in diseases of the ear, such as an otolaryngologist) before purchasing a hearing aid. The hearing health care professional will assess the person's ability to hear sounds and understand others with and without a hearing aid(s), and select and fit a hearing aid(s) to the person's individual communication needs. To find out if an audiologist or hearing aid dispenser is licensed, check with your local Better Business Bureau, consumer protection agency, State Attorney General's office, or the American Speech-Language-Hearing Association (ASHA).

You also have the right to request your hearing evaluation records from your hearing healthcare professional, and may purchase your hearing aid elsewhere (ex: by mail order, subject to state regulations), if desired.

What questions should I ask before buying hearing aids?

Before you buy a hearing aid, consider asking a hearing healthcare professional these questions:

• Which type and style of hearing aids would most meet my needs?
• What special features do my hearing aids need to have to fit my lifestyle?
• Will I need one or two hearing aids?
• What is the total cost of the hearing aids?
• Do the benefits of newer technologies outweigh the higher costs?
• Is there a trial or adjustment period for me to try out the hearing aids? (Most manufacturers allow a trial/adjustment period during which aids can be returned for a refund.)
• What fees are nonrefundable if I return the hearing aids after the trial/adjustment period?
• How long is the warranty? Can it be extended?
• What is covered during the period of warranty? Does the warranty cover future maintenance and repairs? Will loaner aids be provided when repairs are needed?
• How should I care for my hearing aids?

How do I choose hearing aids?

It is important to select the hearing aids that are convenient and easy for you to use, and provide the best compensation for your hearing loss. You will want to wear your hearing aids regularly. Other features to consider include parts or services covered by the warranty, estimated schedule and costs for maintenance and repair, options and upgrade opportunities, and the hearing aid company's reputation for quality and customer service.

You should ask a licensed dispenser if the hearing aids you choose provide a trial/adjustment period during which your hearing aids can be returned for a refund. Most states require a mandatory trial/adjustment period. A trial/adjustment period will allow you to test out your hearing aids to see if it works well for you.

How do I know if hearing aids work for me?

It takes time and patience to get used to hearing aids. You should wear your aids regularly to help you maximize the benefits of your hearing aids. Get familiar with your hearing aids and their features. Practice putting the hearing aids in and taking them out. Learn to adjust the volume in different listening environments. Test your aids in various listening environments and determine where you have problems hearing. The FDA recommends talking to a hearing healthcare professional about any problems hearing with your aids, and have changes made to your hearing aid settings if necessary. We recommend that you work with a hearing healthcare professional until you are comfortable and satisfied with your hearing aids.

How do I care for my hearing aids?

• Proper maintenance and care is important in extending the life of your hearing aids.
• Avoid using solvents, alcohol, or water on hearing aids because they can cause damage to the internal electronics of the hearing aid.
• Avoid exposing hearing aids to heat because this can damage them. For example, leaving them in sun or in the car, placing them in or near a microwave or conventional oven, or using a hair dryer on them.
• Clean hearing aids as instructed. Earwax and ear drainage can damage your aids.
• Avoid using hairspray and other hair care products while wearing your hearing aids.
• Turn off your hearing aids when not in use.
• Replace dead batteries immediately.
• Keep batteries and hearing aids away from children and pets.
• We recommend visiting a hearing healthcare professional on a regular basis to have your hearing aids inspected.

What are hearing aids?

Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment.

Most hearing aids share several similar electronic components, including a microphone that picks up sound; amplifier circuitry that makes the sound louder; a miniature loudspeaker (receiver) that delivers the amplified sound into the ear canal; and batteries that power the electronic parts.

Hearing aids differ by:

• Design
• Technology used to achieve amplification (i.e., analog vs. digital)
• Special features

Some hearing aids also have earmolds or earpieces to direct the flow of sound into the ear and enhance sound quality. The selection of hearing aids is based on the type and severity of hearing loss, listening needs, and lifestyle.

What are the different styles of hearing aids?

Behind-the-ear (BTE) aids: Most parts are contained in a small plastic case that rests behind the ear; the case is connected to an earmold or an earpiece by a piece of clear tubing. This style is often chosen for young children because it can accommodate various earmold types, which need to be replaced as the child grows. Also, the BTE aids are easy to be cleaned and handled, and are relatively sturdy.

"Mini" BTE (or "on-the-ear") aids: A new type of BTE aid called the mini BTE (or "on-the-ear") aid. It also fits behind/on the ear, but is smaller. A very thin, almost invisible tube is used to connect the aid to the ear canal. Mini BTEs may have a comfortable ear piece for insertion ("open fit"), but may also use a traditional earmold. Mini BTEs allow not only reduced occlusion or "plugged up" sensations in the ear canal, but also increase comfort, reduce feedback and address cosmetic concerns for many users.

In-the-ear (ITE) aids: All parts of the hearing aid are contained in a shell that fills in the outer part of the ear. The ITE aids are larger than the in-the-canal and completely-in-the-canal aids (see below), and for some people may be easier to handle than smaller aids.

In-the-canal (ITC) aids and completely-in-the-canal (CIC) aids: These hearing aids are contained in tiny cases that fit partly or completely into the ear canal. They are the smallest hearing aids available and offer cosmetic and some listening advantages. However, their small size may make them difficult to handle and adjust for some people.

What is the difference between analog and digital hearing aids?

Analog hearing aids make continuous sound waves louder. These hearing aids essentially amplify all sounds (e.g., speech and noise) in the same way. Some analog hearing aids are programmable. They have a microchip which allows the aid to have settings programmed for different listening environments, such as in a quiet place, like at a library, or in a noisy place like in a restaurant, or in a large area like a soccer field. The analog programmable hearing aids can store multiple programs for the various environments.

As the listening environment changes, hearing aid settings may be changed by pushing a button on the hearing aid. Analog hearing aids are becoming less and less common.

Digital hearing aids have all the features of analog programmable aids, but they convert sound waves into digital signals and produce an exact duplication of sound. Computer chips in digital hearing aids analyze speech and other environmental sounds. The digital hearing aids allow for more complex processing of sound during the amplification process which may improve their performance in certain situations (for example, background noise and whistle reduction). They also have greater flexibility in hearing aid programming so that the sound they transmit can be matched to the needs for a specific pattern of hearing loss. Digital hearing aids also provide multiple program memories. Most individuals who seek hearing help are offered a choice of only digital technology these days.

What are some features for hearing aids?

Hearing aids have optional features that can be built in to assist in different communication situations. For example:

• Directional microphonemay help you converse in noisy environments. Specifically, it allows sound coming from a specific direction to be amplified to a greater level compared to sound from other directions. When the directional microphone is activated, sound coming from in front of you (as during a face-to-face conversation) is amplified to a greater level than sound from behind you.
• T-coil (Telephone switch) allows you to switch from the normal microphone setting to a "T-coil" setting in order to hear better on the telephone. All wired telephones produced today must be hearing aid compatible. In the "T-coil" setting, environmental sounds are eliminated, and sound is picked up from the telephone. This also turns off the microphone on your hearing aid so you can talk without your hearing aid "whistling."

  The T-coil works well in theaters, auditoriums, houses of worship, and other places that have an induction loop or FM installation. The voice of the speaker, who can be some distance away, is amplified significantly more than any background noise. Some hearing aids have a combination "M" (Microphone) / "T" (Telephone) switch so that, while listening with an induction loop, you can still hear nearby conversation.

• Direct audio input allows you to plug in a remote microphone or an FM assistive listening system, connect directly to a TV, or connect to other devices such as your computer, a CD player, tape player, radio, etc.
• Feedback suppression helps suppress squeals when a hearing aid gets too close to the phone or has a loose-fitting earmold.

The more complicated features may allow the hearing aids to best meet your particular pattern of hearing loss. They may improve their performance in specific listening situations; however, these sophisticated electronics may significantly add to the cost of the hearing aid as well.

What are the benefits of hearing aids?

• You will be able to hear sounds that you have not heard previously.
• You will be able to hear speech over the telephone more clearly.
• You will be able to communicate more easily with family and friends.
• Your ability to communicate may improve in noisy listening situations (e.g. a restaurant or in a large group of people).

Are there limitations with hearing aids?

• Hearing aids do NOT restore normal hearing. In contrast, eyeglasses can restore 20/20 vision.
• Hearing aids amplify all sounds, including background noise that you do not wish to hear.
• Hearing aids require an adjustment period that may take several months. Follow-up visits with the licensed hearing aid dispenser may be needed to take full advantage of the hearing aids.
• When you begin to use hearing aids, many sounds, including your own voice, might seem too loud.
• You will need to learn how to adjust the settings for hearing aids with more complicated technology.
• Hearing aids can be expensive.

To overcome the potential limitations with hearing aids, inclusion of aural rehabilitation during the process of your hearing aid purchase can be helpful. Aural rehabilitation may assist in maximizing the benefits of hearing aids and developing strategies to deal with hearing aid limitations.

Are there safety issues I should know about?

The FDA has issued guidance communicating that we do not intend to enforce the requirement for a medical evaluation or waiver prior to the sale of certain hearing aids for users 18 years of age or older.

While the FDA believes a medical evaluation may not be necessary for people 18 years of age or older before buying hearing aids, if you experience any of the following conditions, you should consult a medical professional:

• Visible deformities of the ear since birth or from injury
• Fluid, pus, or blood coming out of the ear within the previous 3 months
• Sudden, quickly worsening, or fluctuating hearing loss within the previous 3 months
• Dizziness
• Hearing loss in only one ear or a large difference in hearing between ears
• Ear wax build up or feeling that something is in the ear canal
• Pain or discomfort in the ear
• Tinnitus or ringing in one or both of your ears

Some hearing aids require fitting by a licensed hearing healthcare professional (such as an audiologist or a hearing aid dispenser), so that the amplification matches your hearing loss. If not fitted properly, too much amplification may cause additional hearing loss.

What is that buzzing noise in my cell phone?

People who wear hearing aids or have implanted hearing devices may experience some difficulties when trying to use cell phones. That buzzing noise you hear is interference due to radiofrequency (RF) emissions from your phone. RF interference does not occur for all combinations of digital wireless telephones and hearing aids. However, when interference does occur, the buzzing sound can make understanding speech difficult, communication over cell phones annoying, and, in the worst case, render the cell phone unusable for the hearing aid user.

Fortunately, the compatibility of cell phones and hearing aids is improving. Some cell phones have lower radiofrequency emissions or use different technologies that can reduce the unwanted effects on hearing aids.

What should I look for in a cell phone?

Rules set by the Federal Communications Commission (FCC) make it easier for you to choose a cell phone right for you. The FCC requires cell phone manufacturers to test and rate their wireless handsets' hearing aid compatibility using the American National Standards Institute (ANSI) C63.19 standard. These ratings give an indication of the likelihood that a cell phone may interfere with hearing aids; the higher the rating, the less likely the cell phone-hearing aid combination will experience undesired interference.

Labeling on the outside packaging of cell phones will tell you if they are hearing aid compatible (HAC). Hearing aid users should read and understand these ratings when choosing a cell phone.

What do these ratings mean?

Cell phones that are rated "good" or "excellent" for use with hearing aids set in microphone (M) mode will have a rating of M3 or M4. The higher the "M" rating, the less likely you will experience interference when the hearing aid is set in the microphone mode while using the cell phone.

Cell phones are also rated with hearing aids or cochlear implants that have a T-coil. (See Types of Hearing Aids, What are some features for hearing aids?) Those rated "good" or "excellent" for use with hearing aids set in T-coil mode will have a rating of T3 or T4. The higher the "T" rating, the less likely you will experience interference when the hearing aid is set in the T-coil mode while using the cell phone.

Hearing aid manufacturers also use a rating system from the same ANSI standard. The hearing aid ratings and the cell phone ratings should be combined to help identify combinations that will provide you with a positive experience. So, a hearing aid rated M2 and a wireless device rated M3 with a combined rating of 5 and would likely provide "normal" use. A ratings combination of 6 would likely provide "excellent performance". Every individual's hearing aid technology and settings are unique; therefore, these ratings do not guarantee performance.

Because these HAC ratings do not guarantee performance, you should "try before you buy" any wireless device if possible. You should try different brands and models to see which phone works best for you. Also, be sure to closely examine the return policy for the device and the service provider's policy on early termination of contracts before signing up for service.

• Consider going to a doctor. An Ear, Nose, and Throat physician (also known as an ENT or otolaryngologist), can administer a medical exam. The exam will rule out any medical reason for your hearing loss which would require medical or surgical treatment. Your doctor can also give you a referral to an audiologist or a hearing aid dispenser if your health plan requires a doctor's referral for services.
• Consider going to an audiologist. An audiologist will perform an audiological exam to determine the type and amount of your hearing loss, and will counsel you as to your non-medical options to improve your hearing loss.
• Buy your hearing aid either direct-to-consumer, or from a licensed hearing healthcare professional (audiologist, a hearing aid dispenser, or an ear, nose, and throat physician). Ask your hearing healthcare professional to help you determine what features you will need.
• Select your hearing aid carefully. Select one that is convenient and easy for you to use. Buy hearing aids with features that meet your needs in daily listening activities.
• Be sure you know how to care for your hearing aid. Ask a hearing healthcare professional to show you how to clean it and replace the batteries at the time of purchase.
• Ask about a trial/adjustment period. Most manufacturers provide a trial/adjustment period during which your hearing aids can be returned for a refund. A trial/adjustment period will allow you to test out your hearing aids to see if they work well for you.
• Check out the warranty. Like any other product you purchase, be aware of what parts or services are covered by the warranty.