Hearing Professionals

At Eargo, we believe in hearing without compromise and that life deserves to be heard.

We are excited to partner with audiologists to offer our products in your clinics. We believe we have a shared commitment to providing patient-centric solutions for individuals with hearing loss and that we can help to fill a void in your product portfolio with our innovative, open-fit rechargeable completely-in-the-canal (CIC) hearing aids.

We started Eargo with two goals in mind: to build the most revolutionary hearing device the world had ever seen and to put customer experience at the heart of it. Using innovative design, education, and guided support, we offer category-defining differences when it comes to aesthetics, sound, convenience, and affordability.

For your patients with mild to moderate hearing loss, Eargo products deliver sleek design with discretion, comfort, and rechargeability in mind.

We believe in patient-centered care and meeting hearing aid candidates where they are most comfortable, whether that’s in your office or at home.

Eargo Self-Fitting Devices: The Basics

Design – virtually invisible, rechargeable CICs
Sound Quality – custom self-fitting via Sound Match based on NAL-NL2 targets
Technology – app controls, on-ear controls
Support – lifetime customer support
FDA-Cleared and Self-Fitting – Eargo SE, Eargo 6, and Eargo 7

Ideal for open-fit, traditional RIC mild to moderate hearing loss candidates, who want a CIC

What Other Products Does Eargo Offer?

We are excited to offer an FDA-registered preset-based hearing aid, LINK by Eargo. Key features include:

Earbud-style low-profile in-the-ear (ITE) design
4 preset listening programs
Stream phone calls and music with Bluetooth 5.3
Active Noise Cancellation, Noise Reduction, and Feedback Cancellation
Directional microphone processing

Eargo Candidacy

All of our products are meant for users who meet the FDA OTC hearing aid criteria:

Adults 18 years of age or older
Self-perceived mild-to-moderate hearing loss
No red flag conditions. The FDA recommends ENT consult for:
- Congenital or acquired anatomical defect of the ear
- Presence of blood, pus, or drainage from the ear in the last 6 months
- Otalgia
- Excessive cerumen or possible presence of a foreign body in the ear
- Dizziness or vertigo
- Sudden change in hearing in the last 6 months
- Fluctuating hearing loss
- Worse hearing in one ear
- Unilateral tinnitus

Typical Eargo User Characteristics

Open-fit, traditional RIC candidates with mild to moderate hearing loss, who want a CIC
Those who want flexibility in appointment and service options
Those who have interest in ready access to a virtual platform
Patients who aren’t interested in the full commitment of a traditional hearing aid, who like the idea of OTC
As a back-up / “social” hearing aid
Patients concerned with stigma, on the fence, or in denial

…or anyone with self-perceived or diagnosed mild to moderate hearing loss.

Eargo Self-Fitting OTC Product Family

Our products are designed to bring all of the high-tech innovation you expect from the traditional hearing aid model together with all of the benefits and convenience of OTC products.

All of our products are discreet, rechargeable, and come with lifetime support.

Features	Eargo SE	Eargo 6	Eargo 7

Release Year	2024	2022	2023
FDA-Approved OTC Self-Fitting Hearing Aid	Self-fitting via Sound Match (in situ audiometry generating custom gain settings) 4 built-in presets should the user choose not to customize
Discreet	Virtually invisible CIC style
Lifetime Support	Live inbound care for the lifetime of the devices Assigned professional for orientation call How-to videos
Wireless Programming	Yes
Remote Adjustment Capable	Yes
Bluetooth Audio Streaming	No
Ear-Level Controls	Double tap on the tragus to change programs in each ear
Mobile App Controls	Volume Mute Environmental Programs	Volume Mute Treble & Bass Environmental Programs Noise Filter Sound Adjust	Volume Mute Treble & Bass Environmental Programs Noise Filter Sound Adjust+ Clarity/Comfort modes
Response Bandwidth	250-7500 Hz	250-5500 Hz
Rechargeable	Up to 16 hours runtime + 5 recharges from a fully charged case	Up to 16 hours runtime + 2 recharges from a fully charged case
IP Rating	IP54	IPX7
Warranty	1 year with L&D	1 year with L&D	2 years with L&D
MSRP	$1,650/pair	$2,250/pair	$2,950/pair

Eargo Self-Fitting vs. Preset OTC Products

Type of Medical Device

App compatibility

Customization

Form Factor

Connectivity

Firmware Features

Touch Interface

Eargo SE

Eargo 6

Eargo 7

Self-fitting over-the-counter (OTC) hearing aid

Dedicated Eargo mobile app

Remote control from app via Eargo UltraSonic signals (EUS)

Customizable listening programs as well as 4 preset programs

Virtually invisible completely-in-canal (CIC) design

Rechargeable - contact charging

Single microphone

No Bluetooth streaming

Receive updates from Eargo via Bluetooth in Charger

Noise Reduction

Feedback Cancellation

Double-tap accelerometer at ear level

Change to a different listening program

LINK by Eargo

Preset OTC hearing aid (not self-fitting)

No mobile app

Control audio streaming volume and active noise cancellation from connected device via Bluetooth

4 preset programs for mild to moderate hearing loss

Mute program

Low-profile earbud design

Rechargeable

Directional microphones

Truly wireless streaming via Bluetooth 5.3

Stream audio and phone calls

Noise Reduction

Feedback Cancellation

Active Noise Reduction (ANC) in streaming mode only

Capacitive switch at ear level

Turn ANC on/off in streaming mode

Answer/end phone calls

Pause/play audio

What Clinical Evidence Is There to Support Eargo Products?

Our R&D team prides itself on using evidence-based methodologies based on the principles of clinical audiology, acoustics engineering, and hearing science in developing our products. Some of our key efforts are summarized below.

Eargo Sound Match (in situ audiometry) has been validated against audiologist best practices methods in a research collaboration with University of the Pacific¹ (presented at the 2022 IHCON Conference; publication in preparation). In this study (N=100), the accuracy of audiometric thresholds measured with Eargo’s Sound Match feature in a quiet room and in a booth were compared to those measured by an audiologist in a sound treated booth using a clinical audiometer. Results from this study revealed that:
- Statistical equivalence between thresholds measured with Eargo’s Sound Match feature vs. Clinical Audiometry
- Eargo’s Sound Match feature provides an accurate and reliable inference about the hearing status of individuals with and without hearing loss vs. Audiology Best Practice

Comparisons of Eargo Sound Match results measured in a sound treated booth or a quiet room vs. clinical audiogram measured in a booth.

Figure above. Comparisons of Eargo Sound Match results measured in a sound treated booth or a quiet room vs. clinical audiogram measured in a booth.

Figure above. Comparisons of Eargo Sound Match results vs. clinical audiogram in a booth for various configurations.

Eargo’s self-fitting strategy has been validated against audiology best practice methods in research collaboration with University of Minnesota² [ClinicalTrials.gov Identifier: NCT05246904] (presented at the 2022 IHCON Conference; findings submitted for publication). In this single-blind crossover, randomized trial 33 subjects with mild to moderate hearing loss were fit with one of two fitting conditions: 1. Prescriptive-fit based on the subject’s clinical audiogram and fit to NAL-NL2 REAR targets by an audiologist or 2. Self-adjusted fit by subjects using Eargo’s Sound Match and proprietary fitting formula to customize their devices. Subjects wore each fitting for 2-3 weeks, then switched; the fitting condition order was randomized and blinded to the subjects. For each fitting condition, the following key outcomes were measured: REAR to NAL-NL2 targets, Abbreviated Profile of Hearing Aid Benefit (APHAB), speech recognition in noise (AzBio), subjective sound quality ratings, and a system usability scale. Results:
- The field-trial data showed no significant differences across all the objective or subjective outcome measures for audiologist-fitting vs. self-fitting.
- Eargo hearing aids with Sound Match provide the intended population of adults with mild to moderate hearing loss with functional performance that is non-inferior to that provided by a professional hearing aid fitting.

Figure above. Real-Ear Aided Response of audiologist-fit devices and self-fit devices vs. NAL-NL2 moderate targets.

Speech-in-noise (AzBio Scores at +5dB SNR) comparison of audiologist-fit vs. self-fit devices. A non-inferiority (one-tailed test) were not significant at p <0.05; t-value = 0.83; p = 0.21

Figure above. Speech-in-noise (AzBio Scores at +5dB SNR) comparison of audiologist-fit vs. self-fit devices. A non-inferiority (one-tailed test) were not significant at p <0.05; t-value = 0.83; p = 0.21

Figure above. Subjective sound quality ratings of audiologist-fit vs. self-fit devices. A non-inferiority (one-tailed test) on Global APHAB scores were not significant at p <0.05; t-value = -0.08; p = 0.47. APHAB = Abbreviated Profile of Hearing Aid Benefit; EC = Ease of Communication; BN = Background Noise; RV= Reverberation; AV = Aversiveness.

Subjective sound quality ratings of audiologist-fit vs. self-fit devices. A non-inferiority (one-tailed test) on overall sound quality scores were not significant at p <0.05; t-value = 0.52; p = 0.30

Figure above. Subjective sound quality ratings of audiologist-fit vs. self-fit devices. A non-inferiority (one-tailed test) on overall sound quality scores were not significant at p <0.05; t-value = 0.52; p = 0.30

Wearers of Eargo self-fitting OTC devices have shown to have subjective real-world benefit and satisfaction in both retrospective and prospective cohort studies. Results:
- Users of Eargo self-fitting OTC hearing aids experienced a comparable level of overall satisfaction and benefit as those who have been fit with prescription hearing aids.
- Users of Eargo self-fitting OTC hearing aids endorsed improvements over a number of quality of life areas, particularly those related to communication, interpersonal relationships, and social functions.
- Data gathered from new and experienced users of Eargo self-fitting OTC hearing aids suggest that users report a level of satisfaction and subjective benefit equivalent to or better than those experienced by users of prescription hearing aids fit by audiologists following clinical best practice methods.

What Do Eargo Users Have to Say?

In 2023 we surveyed over 800 Eargo self-fitting OTC hearing aid users to evaluate their perceptions and experiences. The survey found:

A majority of respondents feel that their Eargos meet or exceed their expectations
A majority of respondents report being satisfied or very satisfied with their Eargo experience
75% of respondents who had previously used a traditional hearing aid felt that Eargo performance was equal to or better than their traditional hearing aid
83% of respondents who had previously used a traditional hearing aid felt that using and maintaining Eargo devices was equal to or easier than traditional hearing aids
The combination of invisibility and rechargeability was a major motivator
- Only half of respondents were certain they would have still purchased a hearing aid if invisible devices were not available!
2/3 of respondents saw a hearing care professional in person prior to Eargo

Why Partner with Eargo?

Maximize Choice
Fill the void in your product portfolio with an open-fit, rechargeable CIC

Keep It Simple
No need to stock inventory. Let Eargo ship to your office or to your patient, free of charge.

Flexible Support
You and your patient can contact Eargo support at no cost for the lifetime of the hearing aids. Use this as much as you need.

Points to consider:

Eargo products are efficacious and have clinical outcomes on par with prescription products
You can verify and validate Eargo devices using traditional methods
We have in-development fitting software for professionals
You can extend your professional reach
- To those who find the barriers to traditional care to be too much
- To the stubborn CIC-only patient – who needs an open fitting
You can delegate as desired:
- Support at no cost for the lifetime of Eargo SE, Eargo 6, and Eargo 7 hearing aids such as:
  - Troubleshooting, cleaning tips and tricks, remote programming, repairs/ replacements, re-counseling, etc.

2/3 of Eargo users surveyed reported seeing a hearing healthcare provider in-person before purchasing Eargo; if you carry Eargo, you may be able to capture these patients

How Does Partnering with Eargo Work?

Identify your patient who is a candidate for Eargo’s OTC devices
Place an order online or over the phone with Eargo’s professional team
Choose where you want the OTC hearing aids shipped – to your clinic or directly to your patient
Eargo team stands by to help as needed

If you have any questions or would like to learn more about how you can offer our products in your clinic, please don't hesitate to reach out to partners@eargo.com. We value partnering with the audiology community and look forward to working together to improve the lives of those with hearing difficulties.

FAQ

No, all OTC devices are not created equal. The FDA OTC Hearing Aid Final Rule created two distinct categories for hearing aids: prescription and OTC. There are broadly two kinds of OTC hearing aids: those with preset amplification levels with limited customization capabilities and those that are self-fitting.

Self-fitting OTC hearing aids can be customized on an individual’s hearing loss. Self-fitting hearing aids require FDA 510(k) pre-market notification and clearance, which includes submission of clinical data to validate the effectiveness of the self-fitting strategy. Once reviewed and cleared by the FDA, these devices are considered FDA-cleared hearing aids.

Preset-based OTC hearing aids typically have preset settings that are designed to compensate for mild to moderate hearing losses. These devices have limited customization. These devices do NOT require the submission of clinical evidence to the FDA to demonstrate product efficacy. Once the manufacturer registers these devices with the FDA, the devices are considered FDA-registered hearing aids.

Eargo currently offers FDA-cleared self-fitting hearing aids (Eargo SE, Eargo 7, and Eargo 6) and an FDA-registered preset-based hearing aid (LINK by Eargo).

Great question! The design of our ear tips allow for the hearing aid to be suspended in the EAC, allowing for a typical open-fit fitting. We have conducted internal studies to confirm this. For example, in a recent study (N=32 ears), we completed objective and subjective measures of occlusion with the Eargo SE. During this measurement, the subject made a vocalization with a probe microphone in the ear and a microphone outside of the ear with the Eargo SE muted in the EAC. The average occlusion was -2.78 dB (SD= 2.93), meaning there was no objective occlusion noted. 100% of subjects denied subjective occlusion.

Keep in mind that, as with any fitting, individual ear variables impact subjective and objective occlusion, including, but not limited to: ear anatomy, depth of fit, inconsistent placement, tip size, tip type, etc.

Yes, again, keeping in mind that, as with any fitting, individual ear variables impact subjective and objective occlusion, including, but not limited to: ear anatomy, depth of fit, inconsistent placement, tip size, tip type, etc. Eargo devices are designed to compensate for mild to moderate losses. The example data below shows a moderate hearing loss and its real-ear NAL-NL2 match to moderate input targets. For this subject, their fitting had a nice seal allowing for a great target match.

500 Hz	1000 Hz	2000 Hz	3000 Hz	4000 Hz
50	50	60	60	60

Figure above. Real-Ear Aided Response of a subject with moderate thresholds (noted below) wearing Eargo SE with an occlusive physical fit.

Yes, there are multiple ways to verify an Eargo fitting. We recommend using typical clinical practices to verify the fitting, such as speech mapping. To complete an electroacoustic evaluation, ANSI/CTA 2051-2017 standards can be used to verify function of any OTC hearing aid. Using EargoFit software (currently in development) you can also complete an electroacoustic evaluation using ANSI/ASA S3.22-2014 (R2020), just as you would with any prescription device. Click here for device specifications: Eargo SE and Eargo 6 & Eargo 7.

Yes, there are many ways to validate an Eargo fitting. We recommend using typical clinical practices to validate the fitting, such as subjective outcome measures (ex. APHAB, COSI, etc.).

Sound Match is Eargo’s proprietary, app-based method for self determining audiometric thresholds. Sound Match follows a modified Hughson-Westlake threshold search procedure for measuring the audiometric thresholds. It takes ~5-10 minutes to complete. Prior to beginning the assessment, the app completes an environmental noise level check to ensure the user is taking the test in a quiet environment. During Sound Match the Eargo devices are used as the transducer. The thresholds that are derived from the in-situ assessment are then used to prescribe custom gains for each ear.

After completing Sound Match, the user will have a “Normal” program and can select up to 3 environmental programs. Environmental programs use the “Normal” program as a baseline for modifications to advanced features (WDRC, gain, NR, etc.) per environment.

Sound Match is only available in Eargo self-fitting hearing aids (Eargo SE, Eargo 6, and Eargo 7).

If the user opts out of Sound Match, they will default to 4 preset listening programs. As the user progresses through presets 1-4, they will receive increasing levels of amplification that span the mild to moderate hearing loss range.

For users of Eargo self-fitting hearing aids (Eargo SE, Eargo 6, and Eargo 7), numerous adjustments are available:

Volume Control / Mute – these changes are defaulted to binaural, but the user can also make monaural changes
Program Changes – the user can make a binaural change to the program (preset or environment, based on set up)
Noise Filter^† – a temporary binaural change to the noise reduction filtering in poor SNR environments
Sound Adjust^* – automatically detects loud noise and adjusts noise reduction settings for improving listening comfort in high-noise environments while not affecting speech
Sound Adjust+^{^} - all the features of Sound Adjust, plus automatically adapts settings in high-noise or high-noise plus speech environments to optimize for speech clarity or comfort in noise

^†Available on Eargo 6 & Eargo 7 only

^*Available on Eargo 6 only

^{^}Available on Eargo 7 only

There are 5 environmental programs available in Eargo’s self-fitting hearing aids (Eargo SE, Eargo 6, and Eargo 7). They are:

Restaurant - enhances soft, nearby speech while reducing unwanted background noise
Music – optimizes the response to music, using more linear signal processing to reduce distortion and preserve the natural sound of instruments
Meeting – enhances nearby speech in small groups
Phone – optimizes the response for phone use and reduces feedback cancellation for when a phone is held to the ear.
TV – enhances broadcast dialog and prioritizes clarity of speech

References

¹ Hu, J., Kwan, J., Rodriguez, M., Dalager, A., Walters, A., Swaminathan, J. (2022, August 10-14). Verification and Validation of a User Directed Self-Adjustment Hearing Device. International Hearing-Aid Research Conference, Tahoe City, CA.

² Urbanski, D., Nelson, P., Donato, S., Rosenthal, J., Swaminathan, J. (2022, August 10-14). Self-adjustment versus prescriptive fitting: How much of a difference really makes a difference?. International Hearing-Aid Research Conference, Tahoe City, CA.