Eargo 7 is Eargo's first new over-the-counter (OTC) product in 2023. While Eargo 7 is our most revolutionary device yet, it joins Eargo 5 and Eargo 6 as FDA-cleared OTC self-fitting hearing aids, which is very exciting indeed!
What is a 'Self-Fitting' hearing aid?
Self-fitting hearing aids allow users to tailor the amplification and sound quality to their unique hearing needs, without the need for an in-person visit to a clinician’s office to adjust or fit the devices.[1] Given that nearly 45 million adults in the United States experience hearing loss, but only approximately 25% have ever used a hearing aid, we believe that our products have arrived in the FDA OTC Self-Fitting category at a critical moment.[2]
OTC Self-fitting hearing aids might be right for you if you’re experiencing any of the following:
- You have trouble hearing speech in noisy places
- You find it hard to follow speech in groups
- You have trouble hearing on the phone
- Listening makes you tired
- Needing to turn up the volume on the TV or radio, and other people complain it’s too loud
All of these are common signs of mild to moderate hearing loss. In fact, about 28.8 million U.S. adults could benefit from using hearing aids, according to the National Institute on Deafness and other Communication Disorders.[3]
Benefits to the user
One of the main benefits we hope to provide to you with our Eargo OTC self-fitting hearing aids is convenience to adjust or fit your hearing aids to your unique hearing needs. You can complete the entire process in your own home, in under 30 minutes. Discretion is also an important consideration; nobody else needs to know, if that is a concern. No need to travel, carve out time or wait for an appointment; the process is designed to be intuitive and simple.
If you do need assistance, though, you can be reassured that Eargo Support is just a phone call or click away. One additional consideration we’d like to make clear is that we feel that the person with hearing loss is the true expert in their lived experience of it. This is why we have worked to create a self-fitting hearing aid and companion app where you are able to personalize your experience according to your unique needs.
How do you 'self-fit' with Eargo?
The self-fitting functionality is achieved through Eargo’s Sound Match feature. You register, pair and connect your Eargo 5, 6 or 7 system (Charger and Hearing Aids) with our mobile app, which is downloaded from the Apple App or Google Play store. During the guided onboarding process on the app, you will be prompted to run Sound Match.
When running Sound Match, you place the hearing devices in your ear and Sound Match will measure your hearing thresholds for each side. It takes 10-15 minutes to complete. Sound Match then suggests and applies the appropriate sound amplification settings for each ear, based on your hearing loss profile. You can further finetune the hearing aids using the mobile app to customize the sound quality to your liking. Furthermore, you can choose to add up to 3 additional listening programs to suit your lifestyle and preferences, such as Restaurant, Meeting, TV and Phone programs.
How is this process more convenient than traditional in-person fittings?
Traditional in-person fittings require a hearing test in a clinic and often include one or more sessions with a hearing professional on their software to adjust the hearing aid. On the other hand, once you have completed self-fitting the Eargo hearing aids with Sound Match, the Eargo app allows for further sound tuning made by you:
- Change your program selection
- Configure Volume settings for each program, and each ear.
- Configure Treble & Bass settings for each program, and each ear.
- Mute the volume in Left, Right or both ears.
- Configure the Noise Filter for each program, for both ears
You are free to explore Sound Tuning settings in your own way, on your own time. Should you prefer further assistance, follow our in-app “i” information icons to learn more.
Want to speak to someone? The purchase of your Eargo self-fitting hearing aids includes a Welcome Call appointment and lifetime product support. One of our friendly Eargo Hearing Professionals will be happy to help you. You can also re-take Sound Match at any time and reconfigure your devices as often as you need to.
Can a user trust the fitting?
Yes. The FDA cleared Eargo’s 510k submission for the self-fitting functionality based on Eargo’s scientific rigor in the research, development and support of our self-fitting products, Eargo 5, 6, and 7. We apply this scientific rigor so that the FDA and our customers can trust our products and our team. For this specific submission, Eargo conducted studies at three geographically disparate U.S sites to validate the self-fitting strategy of the Eargo Self-Fitting Hearing Aid. The studies focused on 1) validating the accuracy of hearing thresholds measured with Eargo’s Sound Match feature against the hearing thresholds measured by an audiologist following clinical best practice methods, and 2) validating the effectiveness of Eargo’s self-fitting approach in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by an audiologist who followed clinical best practice methods for fitting hearing aids.
Our clinical study participants were adults aged 18 and older with self-perceived hearing difficulties. They reported on three key factors pertaining to sound quality and speech understanding: 1) whether the amplification was appropriate; 2) hearing improvements; and 3) the ease of using the Eargo self-fitting hearing aids. The participants wore the devices for several weeks and took part in validated and standardized laboratory and real-world testing, according to evidence-based practices.
Results from the clinical studies demonstrate the following:
- Eargo’s Sound Match app based feature is as accurate in measuring hearing thresholds as an audiologist following clinical best practice methods;
- Eargo hearing-aids deliver appropriate amplification to meet widely accepted clinical prescription targets for mild to moderate hearing loss; and
- Eargo self-fitting hearing aids provide (a) a reliable self-fitting method for adults with perceived mild to moderate hearing loss and (b) comparable functional performance to traditional, professionally fitted hearing aids.
Eargo is excited to provide its self-fitting hearing aids at a fraction of the cost of traditional fitted hearing aids.
Have further questions or need help with your Eargos? Give us a call at 1 (800) 903-6883.
[1] The FDA does recommend a hearing aid exam with a licensed healthcare provider (preferably an ENT), however, if you have any of the following symptoms:
- Injury to or deformity of the ear
- Fluid, pus, or blood coming from one or both ears
- Sudden or fluctuating hearing loss
- Better hearing in one ear than the other
- Ringing or buzzing in one or both ears
- Constant pain in one or both ears
- Vertigo or dizziness
- A full or plugged feeling in the ear
[2] https://www.hearingloss.org/wp-content/uploads/HLAA_HearingLoss_Facts_Statistics.pdf
[3] https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing#8
