Consumer Resources

CONSIDERING HEARING AIDS?

It's a Bold New World

  1. NEW RULES, NEW CATEGORIES, NEW OPTIONS
    1. The concept of being able to buy lower cost hearing aids that the consumer can adjust is not new, but it has taken a long time to work through the regulatory process. A bill was introduced, passed in Congress, then signed into law in 2017. Then, in October 2021, the FDA released the draft regulations for Over the Counter (OTC) instruments which went into effect a year later on October 17, 2022.
    2. There are different approaches to the categorization of different hearing aids: one is the level of technology; the other is the delivery mode. Prescription and OTC hearing aids have better technology than other consumer offerings, which affects part of their higher cost.
      1. Prescription hearing aids - These are typically the highest level of technology with different features and have the most flexible capability to be programmed specifically for you. They are also available with reduced flexibilities/features in lower priced models. These are fitted, programmed and individualized by a professionally trained and experienced audiologist or Hearing Instrument Specialist. Their time, knowledge and support are factored into the final cost. This is part of an overall treatment plan that you and the professional develop together.
      2. OTC hearing aids - The FDA breaks these into 3 subcategories:
        1. FDA cleared self-fitting or self-adjusting hearing aids, which allow the user to make sound adjustments based on their hearing needs in a particular setting. They are considered a Class II medical device and must be pre-approved for safety and effectiveness by the FDA in accordance with Section 510K prior to releasing them into the marketplace.
        2. FDA registered pre-set hearing aids, which are limited and not customizable by the user. These are considered a Class I medical device and are mostly exempt from the 510K rule. The self-adjustment that may be available is a volume control. They are also known as "Wear-and-Go".
        3. FDA cleared Hearing Aid Feature, most notably the Apple Airpod Pro 2 (and now version 3) coupled with i-phone software.
        4. The Class II OTC hearing aids are meant to be purchased, fit, and adjusted as a do-it-yourself protocol. Class I instruments are not. In both categories, most manufacturers have limited customer support if you need some assistance later.
      3. Direct to Consumer (DTC) hearing aids. These are based on the methods of delivery.
        1. Online Purchases - This method has been around since the late1990s but has increased considerably with online and social media advertising over the last twenty years. You can purchase any type or style hearing aid from a national distribution company. However, you cannot purchase a custom fit prescription hearing aid unless you have an agreement with an audiologist for your fitting. You must have at least a very basic hearing test as a baseline for the initial pro-gramming. If you want an adjustment, you need to send the hearing aids back to the company for the adjustment.
          1. Some Medicare Advantage or Medi-gap supplemental insurance plans have contracts with these companies so they (the insurers) will pay the distributor their agreed upon price for the instruments while you pay for the professional services to the audiologist or hearing instrument specialist for fitting, programming, needed adjustments. and at least one follow-up visit.
        2. Big Box Stores - Costco, Sam's Club and Walmart also carry lower priced prescription, OTC hearing aids and have basic and moderately better hearing aids manufactured by well-known companies, but with modifications to the programing software, a locked chip that can only be programmed by that Company, and sold under a different name brand than the manufacturers generally sell. That's okay while you're around town, but if you travel a lot to other places or countries, there may not be a Costco, Sam's Club or Walmart nearby if you need it. Best Buy or Amazon only carry OTCs or Wear-and-Go type instruments. They are not custom fit and may not even come with a selection of different sized domes to help with stability in the ear canal. (This applies to the completely In-the-Ear style. Most Behind-the-ear models do come with some domes initially.) Afterward, they are a separate cost.
      4. Another item that needs to be defined - Personal Sound Amplifiers. These are not hearing aids. They are not built for anyone with a hearing loss and should not be marketed as hearing aids. They are built with much older, analog technology for people with normal hearing that occasionally may need to hear from a longer distance. One example is for bird watchers, who also may want to hear the bird's call but cannot stand too close. These are the lowest cost instruments that typically cost $50-$60 each. In this instance, you really do, "get what you pay for". The only control you have is a simple volume wheel.
      5. The last item is a consumer device called a Hearable. It's a very vague name for a device that is supposed to help people hear better in a noisy environment. There are no other descriptions or any data on these. Typically, they're sold through social media or on-line. You may hear or see the term but be very cautious. They may or may not be returnable for a refund. Buyer Beware.

Over The Counter Hearing Aids

  1. ARE YOU AN APPROPRIATE CANDIDATE?
    The FDA regulations state that these hearing aids are to be designed for individuals, over 18 years of age, who perceive increasing difficulty hearing and understanding others. Age-related hearing loss refers to a gradual decline in hearing that begins with difficulty hearing high-pitched sounds, impacting clarity. Over several years, this loss extends to lower pitches as well, resulting in reduced sensitivity to volume. As time goes by, this loss of hearing sensitivity continues to slope downward, making hearing worse.
    1. OTC hearing aids are meant to be worn by people in the earlier stages, when their loss is mild to moderate ONLY. If you're frustrated or struggling to hear well in any setting, then your loss may be greater than you realize and not appropriate for these instruments.
    2. Have you had a recent hearing test? Do you know your actual hearing levels? If not, it's highly recommended that you do have it tested beforehand. You'll need that information as a starting point when you begin programming the instruments. Remember, these are self-fitting and you are the person doing the fitting.
    3. While the FDA does not require a hearing test first, it's always considered wise to have a test that includes responding to tones and being tested for speech recognition, both in quiet and against a background of other speech or noises.
    4. If you're considering a self-adjusting or Wear-and-Go type of instrument, the manufacturer will have a short test of tones that you can take over the phone, to give them the starting point.
  2. OTHER CONSIDERATIONS
    1. Finger and hand dexterity - Hearing aids have small parts that go into your ear canals. You need to be able to handle them and place them securely and comfortably in your ears. Additionally, if they do not have rechargeable batteries, then you will need to replace the batteries every 6- 12 days. These are also very small.
    2. Comfortable fit - Whether you choose a Behind-the-Ear or In-the-Ear style, you need to be comfortable with that choice. The portion in the ear needs to be secure and comfortable or you won't want to wear them all day, every day. Many come with an introductory set of rubber "domes" or tips in three different sizes. Find the size that fits you most comfortably and is still secure in your canals. These are not custom fit for you.
    3. If you're not happy with your first choice, return them and try a different style or company. Be sure you know the return policy for either the company, if you purchased directly from the manufacturer, or the retailer where they were purchased. Be sure you know how you will be refunded: by check; posting a credit to the card used when purchased; or a gift card from the retailer so you can use that towards another set. Most companies allow a 45-60 days trial period; be sure you know which applies to you.
    4. Be sure it's compatible with your smartphone. It must have digital technology. Some don't work well with Android phones, although that's changing.
    5. Browse around; there are many different offerings. Read reviews, these are more "real world" than marketing statements. Think about what you want: rechargeable batteries? Bluetooth connectivity? Small size? Are you comfortable using apps on your phone and tasks within those apps? What are your expectations? Be honest with yourself and listen to the other people in your life. They may have some good suggestions or other questions.
  3. WHICH PEOPLE TEND TO BE SUCCESSFUL WITH OTC HEARING AIDS?
    While research studies on this topic are still limited and on-going, early findings suggest that individuals who start earlier in the hearing loss journey, typically in their 50s - 70s, tend to do better than others. This is attributed to:
    1. A realistic assessment of the severity of their hearing loss as being mild to moderate. Many people don't recognize the loss until it's more severe or blame it on something else like, "I wasn't paying attention."
    2. A willingness to self-identify as someone who is becoming hard of hearing
    3. Retaining good cognitive abilities and willing to take proactive steps to maintain it with an active, engaged lifestyle.
    4. Has patience, as this takes some time while becoming proficient using the hearing aids and as your brain adapts to all the new and stronger sounds around you.
    5. Having realistic expectations for these devices as they are not perfect; you'll still have some difficulty in large or noisy settings and no, they will not restore your hearing back to "normal".
  4. PRECAUTIONS - These are not designed for certain conditions such as, but not limited to:
    1. Moderate to severe hearing loss
    2. Hearing loss in only one ear (check with a medical doctor for that)
    3. Underlying medical conditions such as type II Diabetes, a Kidney disorder, Arthritis for which you take a daily medication, a sudden hearing loss or some form of ear infection within the last 3 months, recurring dizziness or feeling off-balance when you stand up or walk around. These last two should be evaluated by a medical ear, nose& throat physician prior to considering any hearing aids

Here's a check-list

Before you buy:

When you're ready to Buy:

After you have bought a pair:

YOU are the person who will make these, "The best hearing aids for me." Prior to purchasing, there is no single pair that lives up to that expectation. You make it your own. Here's how:

Acknowledgements

Many thanks for all the articles I read before starting this endeavor. Specific items referenced include:

Carolyn Drury, President
New Hampshire Academy of Audiology
March 30, 2026