Self-fitting hearing aids empower users to customize amplification and sound quality based on their individual hearing requirements, eliminating the necessity for an in-person clinician visit for adjustments or fittings. Given that nearly 45 million adults in the United States experience varying degrees of hearing loss, yet only approximately 25% have ever actually used a hearing aid, these innovative products may have debuted in the FDA OTC Self-Fitting category at a truly critical moment in time.

With the ability to cater to a currently untapped niche of demand for auditory aids, these cutting-edge devices have the potential to provide a significantly notable boost to the lives of individuals with hearing impairments.

If you’re experiencing any of the following issues, OTC self-fitting hearing aids could possibly be right for you: 

  • Difficulty hearing speech in noisy places
  • Trouble following speech in groups
  • Difficulty hearing on the phone.
  • Listening fatigue
  • Challenges hearing the TV or radio without other people complaining about excessive volume

These are some of the typical indications of mild to moderate hearing loss, according to the National Institute on Deafness and other Communication Disorders (NIDCD). In fact, a staggering number of approximately 28.8 million adults in the United States may benefit from the use of hearing aids, as they can greatly improve their auditory experience. Whether it’s difficulty understanding conversations or missing out on the sounds of everyday life, hearing aids offer a valuable solution to enhance communication and overall lifestyle quality for those with hearing loss.

How Does Self-Fitting Occur?

While the specific methods may vary among devices from different manufacturers, the self-fitting functionality of some devices is achieved through innovative features such as Eargo’s Sound Match. For example, with the Sound Match feature, you register, pair, and connect your self-fitting hearing aids with a mobile app, which can be found on and downloaded from the Google Play or Apple App store. During the guided activation process on the app, you will be prompted to run the Sound Match process.

When running this feature, you place the hearing devices in your ears, and Sound Match will measure your hearing thresholds for each side. It apparently takes approximately 10-15 minutes to complete. Once the measurements are complete, sound Match then suggests and applies what it deems to be the most appropriate sound amplification settings for each ear based on the user’s freshly generated hearing loss profile. You can further configure the hearing aids using the mobile app to tweak and customize the sound quality to your specific liking.

Furthermore, with some devices, you can choose to add additional specialized listening programs to suit your lifestyle and preferences. Some examples are the likes of dedicated Restaurants, Meetings, TV, and Phone programs.

Why Are Self-Fitting Hearing Aids Appealing? 

One of the primary advantages offered by OTC’s self-fitting hearing aids is the improved convenience of tailoring and fitting the devices precisely to your unique hearing requirements. With these innovative devices, you have the freedom to complete the entire adjustment process comfortably in your own home, often within a mere 30 minutes.

Not only does this provide enhanced convenience, but it also helps ensure optimum discretion, giving you greater peace of mind if privacy is a concern. No need to worry about traveling long distances, carving out specific time, or waiting for appointments. The adjustment processes are generally designed to be as intuitive, hassle-free, and delightfully simple as possible. After all, the ideal goal is to ensure a seamless experience for all.

If you find yourself in need of assistance, support is generally available, whether it’s just a phone call or a click away. The specifics and quality, however, can vary depending on the manufacturer. One interesting sentiment that is often expressed by some manufacturers of self-fitting OTC devices is the recognition that the person with hearing loss is the true expert in their own lived experience.

With this understanding, these manufacturers strive to create self-fitting hearing aids and calibration processes that empower users to personalize their experience based on their unique needs, ensuring a truly tailored and satisfying hearing solution.

How Does Self-Fitting Compare To Traditional In-Person Fittings?

self-fitting hearing aids

Traditional in-person fittings require a hearing exam in a clinic and generally include one or more sessions with an audiologist on their software to adjust the hearing device.

On the other hand, once you have completed self-fitting your OTC hearing aids with Sound Match, or whatever other proprietary feature your device manufacturer offers, the accompanying apps or alternative means of adjustment will allow for further sound tuning made by you.

This often includes but is not limited to:

  • Adjusting your program selection
  • Tweaking your Volume settings for each program, and each ear.
  • Modify Treble and bass settings for each program and each ear.
  • Selectively mute the volume in one or both ears.
  • Change the Noise Filter settings for each program for both ears

You are completely free and encouraged to thoroughly explore the various Sound Tuning settings at your own pace and uniquely. Take all the time you need to experiment, tweak, and discover the perfect audio experience that resonates with your individual preferences and elevates your auditory function and comfort to new heights. If you prefer further assistance, you can often contact customer support or find documentation and device configuration instructions in the app or on the manufacturer’s website.

In contrast to a traditional fitting, one of the advantages of Sound Match and other similar configuration processes is that they allow you to re-take the process easily at any time. This means you can fine-tune and reconfigure your devices as frequently as necessary, ensuring optimal settings to meet your specific requirements and preferences. So, whether you’re seeking a slight adjustment or a significant change, you have the flexibility to achieve the perfect configuration for your devices.

Can Self-Fitting Hearing Aids Be Trusted?

Certainly! When it comes to ensuring the safety and effectiveness of self-fitting products, the FDA plays a vital role. The FDA conducts a thorough review of manufacturer submissions, considering factors such as the self-fitting functionality and the scientific rigor of the research and development behind these products. This detailed evaluation provides customers with the confidence to trust products from manufacturers that have received FDA clearance.

For instance, companies like Eargo take it a step further by conducting studies at three geographically diverse locations across the United States. This rigorous validation process helps to authenticate the self-fitting strategy of their exclusive Self-Fitting Hearing Aid. By going above and beyond, these companies focus on delivering top-notch products that meet the highest standards of self-fitting technology.

In the case of Eargo, the studies aimed to achieve two primary objectives. Firstly, they sought to validate the accuracy of hearing thresholds using Eargo’s Sound Match feature. This was done in comparison to hearing thresholds measured by an audiologist who followed established clinical best practices. Secondly, the studies intended to validate the overall effectiveness of Eargo’s self-fitting approach in a clinical trial. This was accomplished by comparing the outcomes of self-fitting hearing aids to those fit by an audiologist who strictly adhered to clinical best practices for fitting hearing aids. The comprehensive nature of these studies ensures a thorough assessment of Eargo’s capabilities and its alignment with FDA standards.

In the case of the Eargo trials, the clinical study participants consisted of adults aged 18 and above who self-perceived hearing difficulties. They volunteered for the study, hoping to find a solution to improve their sound quality and speech understanding. Throughout the study, they provided valuable assessments and feedback on three crucial factors related to their self-fitting device experience: 1) adequacy of amplification, assessing how well it met their needs, 2) improvements in hearing, uncovering the extent of their auditory enhancement, and 3) ease of use of the self-fitting hearing aids, evaluating the simplicity and convenience of this cutting-edge technology.

The specific results from the Eargo clinical studies, in particular, demonstrated the following:

  • Eargo’s Sound Match app-based feature is precise in measuring hearing thresholds, on par with the accuracy of an audiologist employing clinical best practices.
  • Eargo hearing aids provide accurate amplification to meet clinically prescribed targets for mild to moderate hearing loss.
  • Eargo self-fitting hearing aids offer a dependable, self-fitting solution for adults experiencing mild to moderate hearing loss, and performance and function are comparable to more traditional, professionally fitted hearing aids.

Overall, many OTC manufacturers are incredibly enthusiastic about the prospect of offering self-fitting hearing aids that come at a significantly lower price point compared to traditional fitted options. Despite the potential skepticism surrounding these relatively affordable costs, it is worth noting that you can find reassurance in the baseline functional quality of the device as long as it bears the all-important mark of FDA approval. This stamp of regulatory validation further underscores the commitment to ensuring the reliability and performance of these hearing aids, providing consumers with an added level of confidence in their purchase decisions.

Be mindful of FDA Guidance

Although self-fitting hearing aids offer various benefits, it is recommended by the FDA to undergo a traditional hearing aid exam conducted by a licensed healthcare provider, preferably an ENT, if you experience any of the following symptoms:

  • Deformity of, or injury to the ear
  • Blood, pus, or other fluid in general, coming from one or both ears
  • Sudden or fluctuating hearing loss
  • Different levels of hearing in one ear vs the other
  • Tinnitus: Ringing or buzzing in one or both ears
  • Constant pain in one or both ears
  • Vertigo or dizziness
  • A plugged or otherwise full feeling in the ear

Self-Fitting Hearing Aids Takeaway

Ultimately, self-fitting hearing aids can offer a convenient alternative to traditionally fitted devices. By allowing individuals to adjust the device themselves, these aids provide flexibility and empowerment. However, it is important to ensure that your over-the-counter (OTC) self-fitting hearing aid possesses the proper FDA approval and documentation. This ensures the device meets the necessary safety and performance standards to effectively assist with your hearing needs.

Additionally, it is worth noting that a self-fitting hearing aid is typically best suited as an option for individuals with only mild to moderate hearing loss.Considering these elements can help you make an informed decision about incorporating this innovative technology into your daily life. Remember, the goal is to improve your hearing experience and enhance your overall quality of life.

Head Hearing Health Clinician at Florida Hearing Institute | + posts

Florida License: AS-2471 – NPI: 1992749147

Ivonne Baixeras is a Florida-Licensed Hearing Instrument Specialist with a track record of almost three decades treating hearing problems in Miami-Dade County and serving the needs of thousands of satisfied patients. Ivonne is a graduate of both Miami-Dade College & Florida International University and worked for many years at the largest national chain of hearing clinics in the US where she's received multiple awards.

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