Eargo 5 , Eargo 6

K221698 · Eargo, Inc. · QUH · Dec 21, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K221698
• Device Name: Eargo 5 , Eargo 6
• Applicant: Eargo, Inc.
• Product Code: QUH · Ear, Nose, Throat
• Decision Date: Dec 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3325
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.

Device Story

Eargo Self-Fitting Hearing Aids are CIC (completely-in-canal) devices for mild-to-moderate hearing loss. Input: ambient sound via single omnidirectional microphone. Processing: 8-channel WDRC, noise reduction, feedback cancellation. Output: amplified sound. Operation: user-controlled via mobile app (iOS/Android) or on-device accelerometer. Self-fitting: proprietary 'Sound Match' app-based threshold assessment determines gain profiles. Connectivity: Bluetooth Low Energy (BLE) for firmware/programming; proprietary ultrasonic (EUS) for app-to-aid communication. Power: rechargeable Li-ion batteries; charging case uses near-field inductive charging. Benefit: allows independent, professional-free hearing aid fitting and adjustment, improving speech intelligibility and sound quality in real-world environments.

Clinical Evidence

Clinical validation included 100 subjects for Sound Match threshold accuracy and 33 subjects for self-fitting effectiveness. Primary endpoints: audiometric threshold accuracy vs. audiologist best practice; REAR (Real-Ear Aided Response) vs. NAL-NL2 targets; APHAB global scores; speech-in-noise intelligibility (AZBio). Results: Sound Match thresholds comparable to clinical standards (p>0.05); self-fit REAR RMSE <5dB from targets; APHAB and speech-in-noise scores non-inferior to audiologist-fit. Usability studies (n=255) confirmed high user satisfaction.

Technological Characteristics

CIC form factor; single omnidirectional microphone; 8-channel WDRC; rechargeable Li-ion battery (IEC 62133-2:2017); wireless near-field inductive charging. Connectivity: BLE 5.0 and proprietary EUS protocol. Standards: ANSI/ASA S3.22-2014, IEC 60601-1, IEC 60601-2-66, IEC 60118-13. Software: firmware updates via mobile app.

Indications for Use

Indicated for individuals 18 years of age or older with perceived mild to moderate hearing impairment. No contraindications specified.

Regulatory Classification

Identification

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.

Special Controls

In combination with the general controls of the FD&C Act, the self-fitting air-conduction hearing aid is subject to the following special controls: - 1. Clinical data must evaluate the effectiveness of the self-fitting strategy. - 2. Electroacoustic parameters, including maximum output limits, distortion levels, selfgenerated noise levels, latency, and frequency response, must be specified and tested. - 3. Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. - 4. Software verification, validation, and hazard analysis must be performed. - 5. If the device incorporates wireless technology: - (A) Performance testing must validate safety of exposure to non-ionizing radiation; - (B)Performance data must validate wireless technology functions; and - (C) Labeling must specify instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation. - 6. Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. - 7. Patient labeling must include the following: - (A)Information on how a patient can self-identify as a candidate for the device; - (B) Information about when to seek professional help; - (C) A warning about using hearing protection in loud environments; - (D) A warning about staying alert to sounds around the user of the device; - (E) Technical information about the device, including information about electromagnetic compatibility; and - (F) Information on how to correctly use and maintain the device.

*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy. (2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested. (3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) If the device incorporates wireless technology: (i) Performance testing must validate safety of exposure to non-ionizing radiation; and (ii) Performance data must validate wireless technology functions. (6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.

Predicate Devices

• Bose SoundControlTM Hearing Aids (K211008)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 21, 2022

Eargo, Inc. Monica Barrett Sr. Dir. RAQA 2665 North First Street, Suite 300 San Jose, California 95134

Re: K221698

Trade/Device Name: Eargo Self-Fitting Hearing Aids Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: November 21, 2022 Received: November 22, 2022

Dear Monica Barrett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221698

Device Name Eargo Self-Fitting Hearing Aids

### Indications for Use (Describe)

The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing imparment in individuals 18 years of age or older. They are to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.

Type of Use (Select one or both, as applicable)

| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------|-----------------------------------------------|
|------------------------------------------------|-----------------------------------------------|

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# 510(k) Summary

510(k) Applicant Monica Barrett Sr. Director, RAQA Eargo, Inc. 2665 N. 1st Street, Suite 300 San Jose, CA 95134 Tel: [phone] monica.barrett(@eargo.com

| Contact Person: | Monica Barrett, Eargo, Inc. |
|--------------------|-----------------------------------------------------------|
| Phone: | 916.849.5399 |
| Email: | [e-mail] |
| Date of Summary: | 12 December 2022 |
| Trade Name: | Eargo Self-Fitting Hearing Aid Family of products |
| Models: | Eargo 5, Eargo 6 |
| Common Name: | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Regulation Name: | Self-Fitting Air-Conduction Hearing Aid |
| Regulation Number: | 21 CFR 874.3325 |
| Product Code: | QUH |
| Classification: | Class II |

Panel: Ear Nose & Throat

- PREDICATE DEVICE

| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---------------|------------------------------------|------------------|
| K211008 | Bose SoundControlTM Hearing Aids | Bose Corporation |

# · DEVICE DESCRIPTION

The Eargo Self-Fitting Hearing Aid is a self-fitting air-conduction hearing aid system that incorporates wireless technology in its programming and use. The hearing aid system consists of a pair of earbud-style hearing aids (left and right), a charging case, and a companion mobile application (app) available for iOS (version 12 or later) and Android (version 7 or later) mobile devices. The hearing aids are designed to be virtually invisible, inserted completely and discreetly within the ear canal. Each hearing aid contains a microphone to allow for audio input, which is amplified by the hearing aid. The mobile

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app facilitates Eargo's proprietary self-fitting process using a combination of proprietary ultrasonic (for fitting) and Bluetooth Low Energy (BLE; for programming fitting settings) wireless communication. The mobile app also allows the user to control the hearing aids using proprietary ultrasonic wireless communication and enables firmware updates to the hearing aid system via BLE. App-based user controls include program and settings changes. In addition, each hearing aid contains an accelerometer sensor that allows for ondevice user control of the hearing aids. On-device user controls allow the user to make program changes without the mobile app. Each hearing aid contains a rechargeable Li-ion battery and is charged by the charging case that also functions as a carrying case. The charging case contains a single-cell Li-ion rechargeable battery, which charges the hearing aids via wireless (near-field inductive) charging when the hearing aids are correctly placed into the charging case.

Image /page/4/Figure/3 description: The image shows a diagram of the Eargo hearing aid system. The diagram shows the Eargo hearing aid, the Eargo hearing aid charger, and the Eargo mobile app. The Eargo hearing aid communicates with the Eargo mobile app via Bluetooth Low Energy (BLE) and Wireless Eargo UltraSonic(EUS) Communication Protocol. The Eargo hearing aid charger communicates with the Eargo hearing aid via Eargo proprietary Charger Communication Protocol.

Figure 1: Eargo Self-Fitting Hearing Aid Communication Pathways

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- · INTENDED USE
The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older.

- · Indications for Use
The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.

- · SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Both the Eargo Self-Fitting Hearing Aids (subject device) and the predicate device, the Bose SoundControl™ Hearing Aid (K211008), are self-fitting wireless air-conduction sound amplifying devices intended to compensate for perceived impaired hearing in individuals aged 18 years and older. Both the subject and predicate devices incorporate technology that integrates user input with a self-fitting strategy that enables users to independently derive and customize their hearing aid fitting and settings.

Both the subject and predicate devices share the following similar technological characteristics:

- Mobile app-based (wireless) self-fitting strategy ●
- Acoustic performance adequate for the intended use ●
- Mobile app-based (wireless) and on-device user controls for fitting and ● customization
- Mobile app-supported (wireless) system firmware updates ●
- Different sized eartips in open and closed styles
- Acoustic performance features (noise reduction, feedback cancellation) ●

The Eargo Self-Fitting Hearing Aids include the following:

- · Completely in the canal (CIC) form factor with single omnidirectional microphone
- . Independent treble, bass, and noise reduction user controls
- Independent left and right hearing aid customization
- Rechargeable hearing aids ●

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- • Rechargeable charger case
- Proprietary ultrasonic wireless communication to hearing aids .

Table 1 discusses the comparison between the Eargo Self Fitting Hearing Aid (subject device and the Bose SoundControl™ Hearing Aid (predicate device)

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# Table 1: Comparison

| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Self-fitting air conduction hearing aid | Self-fitting air conduction hearing aid | The device type is the same as the predicate. |
| Indications for<br>Use | Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional. | The Bose SoundControlTM hearing aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre- programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional. | The indications for use are similar to the predicate except for the last sentence. The difference in the final sentence does not raise different questions of device safety and effectiveness. |
| Intended Use | The Eargo Self-Fitting Hearing Aid are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. | The Bose SoundControlTM hearing aids are a pair of user-fitted wireless air conduction hearing aids intended for use by individuals 18 years and older with perceived mild to moderate hearing impairment. | The intended use is the same as the predicate. |
| Technology | Self-fitting air conduction hearing aid incorporating wireless technology | Self-fitting air conduction hearing aid incorporating wireless technology | The technology is the same as the predicate. |
| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
| Form Factor | Traditional CIC (completely in<br>canal) form factor. Non-custom,<br>separate left and right ear units. User-<br>replaceable eartips come in different<br>sizes.<br>Image: Eargo Self Fitting Hearing Aid | Traditional receiver in the canal<br>(RIC) and behind the ear (BTE)<br>form factor. Non-custom, separate<br>left and right ear units. User-<br>replaceable eartips come in different<br>sizes. Factory replaceable wire cable<br>comes in different sizes.<br>Image: Bose SoundControl Hearing Aid | The subject device form factor is a<br>wireless CIC and the predicate<br>device form factor is a RIC/BTE<br>with wired earbuds, data from<br>biological safety testing, usability<br>testing, and clinical validation data<br>support substantial equivalence<br>with the predicate device. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControlTM Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| Wireless<br>Communication<br>Mobile app (via<br>smartphone/mo<br>bile device) to<br>hearing aid<br>system | Wireless communication between the<br>mobile app and the hearing aid<br>system occurs in two ways:<br>1) Mobile app to hearing aids:<br>Wireless communication from the<br>mobile app to the hearing aids is<br>done via a proprietary Eargo<br>UltraSonic (EUS) communication<br>protocol. App to hearing aid<br>communication via EUS supports<br>Sound Match self-fitting, and<br>program and settings changes to the<br>hearing aids.<br>2) Mobile app to charger case:<br>Wireless communication from the<br>mobile app to the charger case is<br>done via 2.4GHz Bluetooth 5.0 Low<br>Energy (BT5.0 LE). App to charger<br>case communication via BT5.0 LE<br>supports hearing aid programming,<br>system info recognition by the app,<br>and delivering firmware updates to<br>the hearing aid system. | Wireless communication between<br>the mobile app and the hearing aids<br>occurs via the 2.4GHz Bluetooth<br>Low Energy (BLE) standard. App to<br>hearing aid communication via BLE<br>supports self-fitting (i.e., listening<br>mode and settings changes) and<br>firmware updates. | Wireless (app-based) user controls of<br>the subject device, such as self-fitting,<br>program and setting changes etc. are<br>achieved via EUS. Additional app-<br>based user controls related to<br>programming, recognizing, and<br>updating the hearing aids are facilitated<br>by a BT5.0 LE connection between the<br>app and the charger.<br>The technological differences of the<br>subject device + mobile product/App<br>(using EUS) versus the predicate +<br>mobile device/its App (using Bluetooth<br>LE) are supported by usability testing<br>of the subject device. This usability<br>testing demonstrated both user<br>satisfaction and ease of use for EUS<br>control of the Eargo hearing aids.<br>While the communication protocols<br>differ between the subject and predicate<br>devices, the overall wireless-supported<br>functions and connectivity/electrical<br>safety risks are similar and do not raise<br>different questions of device safety and<br>effectiveness. |
| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
| Bluetooth<br>Pairing and<br>Control | Pairing, control, and verification with<br>the paired mobile device are done via<br>the charger case. | Pairing, control, and verification<br>with the paired mobile device are<br>done via the hearing aids. | While the pairing process differs<br>between subject and predicate devices,<br>they are using the same technology.<br>These differences do not raise different<br>questions of safety and<br>effectiveness. |
| | | | Data from wireless performance<br>testing support substantial<br>equivalence. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControl™ Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| Battery | Eargo Self Fitting Hearing Aids are<br>rechargeable, with the hearing aids<br>charged inside a proprietary portable<br>charger case via wireless (near-field<br>inductive) charging.<br>The charger case contains a Li-ion<br>battery that provides up to 3 hearing<br>aid use cycles (for a pair of hearing<br>aids) on a single full charge,<br>depending on use. The charging case<br>supports both self-powered operation<br>and/or being powered by a standard<br>USB-C cable connected to a power<br>supply. When connected to a USB<br>power supply, the internal battery is<br>recharged, allowing for subsequent<br>on-the-go charging of hearing aids.<br>Eargo hearing aids house a small<br>capacity secondary type<br>(rechargeable) Li-Ion battery that is<br>certified to IEC 62133-2:2017. The<br>battery allows for up to 16 hours of<br>runtime, depending on use. | Bose SoundControl Hearing Aids<br>require single-use Size 312 primary<br>type (non-rechargeable) Zn-Air<br>batteries. | The subject device is rechargeable<br>between use cycles, while the<br>predicate device uses replaceable<br>batteries. The differences in battery<br>type and capacity do not raise<br>different questions of safety or<br>effectiveness.<br>Data from battery safety testing<br>support substantial<br>equivalence. |
| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
| Microphones | Subject device CIC hearing aids each<br>contain a single omnidirectional<br>microphone to allow for acoustic<br>input. | Predicate device BTE hearing aids<br>contain microphones that may,<br>during use, be configured by the user<br>in omnidirectional or directional<br>modes. | The predicate device has a RIC/BTE<br>form factor with two microphones that<br>can be configured in omnidirectional<br>or directional modes.<br>The subject device has a single<br>omnidirectional microphone not<br>configurable by the user. The subject<br>device though is completely in canal<br>(CIC) style hearing aid allowing the<br>user to use natural pinna cues for<br>directionality.<br>Clinical validation data support<br>substantial equivalence with the |
| | | | predicate device. |
| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
| User/Device<br>Controls | On-device user controls:<br>- User-selectable<br>- Programs/Environments<br>(i.e., Eargo-recommended<br>gain offsets).<br>App-based user controls:<br>- Volume<br>- Mute<br>- Treble and bass<br>(independent adjustment)<br>- Left/Right/Both<br>(independent adjustment)<br>- Program/Environment (user-<br>customizable Eargo-<br>recommended gain offsets)<br>- Noise Filter adjustment<br>- Bluetooth pairing with<br>Eargo Charger | On-device user controls:<br>- Power on/off<br>- World Volume<br>App-based user controls:<br>- World Volume<br>- Treble and bass (balance<br>adjustment)<br>- Focus (mic directionality)<br>- Left/Right (balance<br>adjustment)<br>- Modes (Bose-recommended<br>gain profiles, user-<br>customizable)<br>- Bluetooth pairing with<br>hearing aids | The combined suite of on-device<br>and app-based user controls of<br>hearing aids are comparable<br>between the subject and predicate<br>devices.<br>The predicate device's "Focus"<br>feature is specific to the<br>microphone configuration of its<br>RIC/BTE form factor, which<br>benefits from the ability to change<br>directionality modes. The subject<br>device's CIC form factor utilizes an<br>omnidirectional microphone<br>configuration that sits within the ear<br>canal when inserted into the ear and<br>leverages the natural directional<br>characteristics of the head and<br>pinna during normal use.<br>Other differences in feature<br>implementation and adjustability do not<br>raise different questions of safety and<br>effectiveness. |
| Over The Air<br>(OTA)<br>Firmware<br>Update | The hearing aids automatically<br>update when connected to the mobile<br>app. The Eargo Mobile app allows<br>for remote firmware update of the<br>hearing aids. | The hearing aids automatically<br>update when connected to the mobile<br>app. | The firmware update process is the<br>same as predicate. |
| Feature/<br>Attribute | Eargo Self Fitting Hearing Aid<br>(Subject Device) | Bose SoundControlTM Hearing Aid<br>(Predicate Device) | Discussion |
| Compression | The subject device uses 8-channel wide dynamic range compression (WDRC). | The predicate device uses 12-channel wide dynamic range compression (WDRC). | The 8-channel WDRC settings in the subject device and the 12-channel WRDC settings in the predicate device operate across similar overall frequency/bandwidth ranges, and both allow only gross adjustments to spectral tilt via bass and treble controls.<br>This difference does not raise different questions of safety and effectiveness.<br>Data from a clinical validation study support substantial equivalence. |
| Noise<br>Reduction | The subject device utilizes a fast-acting noise reduction algorithm to reduce noise between sentences, words and syllables & to improve speech perception when background stationary/steady-state noises (such as vacuum cleaners, air conditioners, etc.) are present. This feature is user adjustable. | The predicate device utilizes a noise reduction approach when steady-state noises are detected. | Noise reduction is the same as the predicate. |
| Feedback<br>Cancellation | The subject device utilizes a feedback canceller. | The predicate device utilizes a feedback canceller. | Feedback cancellation is the same as the predicate. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControlTM Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) |…