(191 days)
Not Found
No
The summary describes a self-fitting process using proprietary ultrasonic and Bluetooth communication for programming and control, but does not mention the use of AI or ML algorithms for this fitting or any other function. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to amplify and transmit sound to the ear to compensate for perceived mild to moderate hearing impairment, which is a therapeutic function.
No
Explanation: The device description states, "No pre-programming or hearing test is necessary." While the device performs "self-fitting" and measures "hearing thresholds" for programming, its primary stated purpose is amplification of sound for hearing impairment, not the diagnosis of a medical condition. The "Sound Match" feature is used to adjust the hearing aid settings, not to provide a medical diagnosis of hearing loss.
No
The device description clearly states that the system consists of hearing aids (hardware), a charging case (hardware), and a mobile application (software). While the mobile app facilitates the self-fitting process and controls, the core function of amplifying and transmitting sound is performed by the physical hearing aids.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment". This describes a therapeutic or assistive device, not a diagnostic one.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The description details a hearing aid system that amplifies sound and is adjusted by the user. It does not involve the examination of any specimens from the human body.
- Lack of Diagnostic Function: The device's function is to compensate for hearing impairment by amplifying sound, not to diagnose the cause or nature of the hearing impairment through in vitro testing. While it includes a "Sound Match" feature for self-fitting, this is a method for the user to adjust the device's settings based on their perception of sound, not a diagnostic test performed on a biological sample.
In summary, the Eargo Self-Fitting Hearing Aids are designed to assist individuals with hearing impairment by amplifying sound, which is a therapeutic/assistive function, not a diagnostic one involving in vitro examination of specimens.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
QUH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Used without the assistance of a hearing care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Validation of Eargo's Sound Match Hearing Thresholds Against Audiology Best Practice:
Sample Size: 100 subjects (76 with hearing loss, 24 with normal hearing).
Data Source: University of the Pacific (San Francisco and Stockton campuses).
Annotation Protocol: Subjects were tested across three conditions:
- Air-conduction audiometric thresholds obtained by an Audiologist in a sound-treated booth, following Audiology best practice methods (ABP).
- Subject-determined air-conduction audiometric thresholds using Eargo Sound Match in a sound-treated booth (EargoA).
- Subject-determined air-conduction audiometric thresholds using Eargo Sound Match in a quiet room (EargoB).
Clinical Verification of Eargo's Self-Fitting Approach:
Sample Size: 33 subjects (18 female, 15 male), aged between 24 to 83 years, with predominantly mild-to-moderate hearing loss in both ears.
Data Source: Center for Applied and Translational Sensory Science at the University of Minnesota.
Annotation Protocol: A within-subject, crossover design was used. Participants completed two field trial hearing aid fitting conditions (self-fit and audiologist-fit hearing aids), with the order randomized. After each field trial, participants visited the lab to complete study outcome measures. Participants wore devices for each fitting condition for 2-3 weeks in the field and were blinded to the fitting approach.
- Initial visit: Participants completed a standard clinical hearing test and self-measured their hearing thresholds using Eargo's Sound Match feature.
- Audiologist-fit condition (AUD-fit): A research audiologist used clinical best practice methods to match Real Ear Aided Response (REAR) to NAL-NL2 targets from .25-4kHz within 3 dB of the target gain. Programming changes were made using Eargo Fitting Software. Participants could request further adjustments. REAR was recorded after adjustments.
- Self-fit condition: Thresholds measured using Eargo's Sound Match feature were mapped to an audiogram from a pre-populated list. Hearing aid fitting parameters (based on a proprietary fitting formula) were loaded into the devices. Participants could self-adjust treble, bass, and overall volume using the Eargo app. REAR was recorded after participants made adjustments.
- All real-ear measures were recorded using the International Speech Test Signal (ISTS) at 65 dB SPL.
Sound quality satisfaction survey:
Sample Size: 255 survey respondents.
Data Source: Hearing impaired individuals who have used Eargo devices (hearing aids and the Eargo mobile app) in the field for two months or longer.
Annotation Protocol: Survey participants were asked about their satisfaction with the device's sound quality across a range of situations and environments (including speech perception in various contexts, including in noise, listening to music, watching TV, etc.) following device use in the real world.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation of Eargo's Sound Match Hearing Thresholds Against Audiology Best Practice:
Study type: Clinical study comparing self-measured thresholds to audiologist-measured thresholds.
Sample size: 100 subjects.
Key results:
- EargoA thresholds were comparable to ABP across all frequencies tested.
- Pairwise t-test showed no statistically significant differences between EargoA thresholds and clinical thresholds at all frequencies tested.
- With respect to test-retest reliability, thresholds were comparable between EargoA and EargoB across all frequencies tested.
- Pairwise t-test showed no statistically significant differences between EargoA and EargoB thresholds.
- System Usability Scale (SUS) mean overall score was 71, comparing favorably to the industry benchmark of 68, suggesting easy and independent self-measurement of audiometric thresholds.
Clinical Verification of Eargo's Self-Fitting Approach:
Study type: Clinical trial validating self-fitting approach.
Sample size: 33 subjects.
Key results:
- No significant differences were noted between real-ear gain measured between self-fit and AUD-fit settings.
- Average Root Mean Square Error (RMSE) from NAL-NL21 targets at 250 Hz, 1 kHz, 2 kHz and 4 kHz were below 5 dB for both fitting conditions.
- Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire: Very similar aided mean and standard deviation values for self-fit, and AUD-fit across APHAB subscales and the overall APHAB-global score, demonstrating substantial equivalence between the two fitting approaches.
- Aided speech in noise understanding (AZBio sentences): Very similar mean and standard deviation values when comparing the aided speech in noise scores for the two fitting approaches (AUD: ~88% correct, SELF: ~87% correct).
- Subjective sound quality ratings: Very similar mean and standard deviation scores when comparing the overall sound quality ratings for the two fitting approaches.
Real-World Evaluation of Fit and Comfort:
Study type: Long-term, real-world usability study.
Sample size: 33 participants.
Key results:
- 88% rated fit of the device as "Good" or "Excellent".
- 94% rated migration as "Never" or "1-2 times daily".
- 94% rated discomfort as "Mild" or "No Discomfort".
Real-World Evaluation of Safety:
Study type: Long-term, real-world usability study.
Sample size: 31 participants.
Key results:
- No health-related issues due to device fit or discomfort were observed.
- No device failures leading to potential safety issues were observed.
Real-World Evaluation of Satisfaction and Usability:
Study type: Web-based survey study.
Sample size: 255 subjects.
Key results:
- Acceptable usability and satisfaction in all assessed areas, including Sound Match completion, device maintenance and cleaning, subjective sound quality, app-based adjustments, and perceived benefit.
Human Factors Validation of Self-Fit Strategy:
Study type: Human factors validation test (summative usability test).
Sample size: 16 participants.
Key results:
- All four use case scenarios (Completing Sound Match, Using mobile app to change programs/settings, Making in-situ program changes without mobile app, Reverting settings back to factory defaults) met the acceptance criteria of being completed successfully by at least 80% of participants.
- No use errors (failure or inability to complete) were observed for any tasks within any scenarios.
Human Factors Validation of Device Labeling and Device Handling/Maintenance:
Study type: Human factors validation test.
Sample size: 24 participants.
Key results:
- All six use case scenarios (Understanding of outside the package device labeling, Understanding/acknowledgement of inside the package device labeling, Device charging, Eartip self-selection, replacement, and device insertion/removal, Mic cap replacement, Device cleaning) met the acceptance criteria of being completed successfully and independently by at least 80% of participants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Speech in Noise Intelligibility showed 88% correct for AUD and 87% correct for SELF.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
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.(b)
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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: 916.849.5399 monica.barrett(@eargo.com
| Contact Person: | Monica Barrett, Eargo, Inc. |
|---|---|
| Phone: | 916.849.5399 |
| Email: | monica.barrett@eargo.com |
| 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
4
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
5
-
· 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 ●
6
- • 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/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(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
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/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(Predicate Device) | Discussion |
| Form Factor | Traditional CIC (completely in
canal) form factor. Non-custom,
separate left and right ear units. User-
replaceable eartips come in different
sizes.
Image: Eargo Self Fitting Hearing Aid | Traditional receiver in the canal
(RIC) and behind the ear (BTE)
form factor. Non-custom, separate
left and right ear units. User-
replaceable eartips come in different
sizes. Factory replaceable wire cable
comes in different sizes.
Image: Bose SoundControl Hearing Aid | The subject device form factor is a
wireless CIC and the predicate
device form factor is a RIC/BTE
with wired earbuds, data from
biological safety testing, usability
testing, and clinical validation data
support substantial equivalence
with the predicate device. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControlTM Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| Wireless
Communication
Mobile app (via
smartphone/mo
bile device) to
hearing aid
system | Wireless communication between the
mobile app and the hearing aid
system occurs in two ways:
- Mobile app to hearing aids:
Wireless communication from the
mobile app to the hearing aids is
done via a proprietary Eargo
UltraSonic (EUS) communication
protocol. App to hearing aid
communication via EUS supports
Sound Match self-fitting, and
program and settings changes to the
hearing aids. - Mobile app to charger case:
Wireless communication from the
mobile app to the charger case is
done via 2.4GHz Bluetooth 5.0 Low
Energy (BT5.0 LE). App to charger
case communication via BT5.0 LE
supports hearing aid programming,
system info recognition by the app,
and delivering firmware updates to
the hearing aid system. | Wireless communication between
the mobile app and the hearing aids
occurs via the 2.4GHz Bluetooth
Low Energy (BLE) standard. App to
hearing aid communication via BLE
supports self-fitting (i.e., listening
mode and settings changes) and
firmware updates. | Wireless (app-based) user controls of
the subject device, such as self-fitting,
program and setting changes etc. are
achieved via EUS. Additional app-
based user controls related to
programming, recognizing, and
updating the hearing aids are facilitated
by a BT5.0 LE connection between the
app and the charger.
The technological differences of the
subject device + mobile product/App
(using EUS) versus the predicate +
mobile device/its App (using Bluetooth
LE) are supported by usability testing
of the subject device. This usability
testing demonstrated both user
satisfaction and ease of use for EUS
control of the Eargo hearing aids.
While the communication protocols
differ between the subject and predicate
devices, the overall wireless-supported
functions and connectivity/electrical
safety risks are similar and do not raise
different questions of device safety and
effectiveness. |
| Feature/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(Predicate Device) | Discussion |
| Bluetooth
Pairing and
Control | Pairing, control, and verification with
the paired mobile device are done via
the charger case. | Pairing, control, and verification
with the paired mobile device are
done via the hearing aids. | While the pairing process differs
between subject and predicate devices,
they are using the same technology.
These differences do not raise different
questions of safety and
effectiveness. |
| | | | Data from wireless performance
testing support substantial
equivalence. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControl™ Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| Battery | Eargo Self Fitting Hearing Aids are
rechargeable, with the hearing aids
charged inside a proprietary portable
charger case via wireless (near-field
inductive) charging.
The charger case contains a Li-ion
battery that provides up to 3 hearing
aid use cycles (for a pair of hearing
aids) on a single full charge,
depending on use. The charging case
supports both self-powered operation
and/or being powered by a standard
USB-C cable connected to a power
supply. When connected to a USB
power supply, the internal battery is
recharged, allowing for subsequent
on-the-go charging of hearing aids.
Eargo hearing aids house a small
capacity secondary type
(rechargeable) Li-Ion battery that is
certified to IEC 62133-2:2017. The
battery allows for up to 16 hours of
runtime, depending on use. | Bose SoundControl Hearing Aids
require single-use Size 312 primary
type (non-rechargeable) Zn-Air
batteries. | The subject device is rechargeable
between use cycles, while the
predicate device uses replaceable
batteries. The differences in battery
type and capacity do not raise
different questions of safety or
effectiveness.
Data from battery safety testing
support substantial
equivalence. |
| Feature/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(Predicate Device) | Discussion |
| Microphones | Subject device CIC hearing aids each
contain a single omnidirectional
microphone to allow for acoustic
input. | Predicate device BTE hearing aids
contain microphones that may,
during use, be configured by the user
in omnidirectional or directional
modes. | The predicate device has a RIC/BTE
form factor with two microphones that
can be configured in omnidirectional
or directional modes.
The subject device has a single
omnidirectional microphone not
configurable by the user. The subject
device though is completely in canal
(CIC) style hearing aid allowing the
user to use natural pinna cues for
directionality.
Clinical validation data support
substantial equivalence with the |
| | | | predicate device. |
| Feature/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(Predicate Device) | Discussion |
| User/Device
Controls | On-device user controls:
- User-selectable
- Programs/Environments
(i.e., Eargo-recommended
gain offsets).
App-based user controls: - Volume
- Mute
- Treble and bass
(independent adjustment) - Left/Right/Both
(independent adjustment) - Program/Environment (user-
customizable Eargo-
recommended gain offsets) - Noise Filter adjustment
- Bluetooth pairing with
Eargo Charger | On-device user controls: - Power on/off
- World Volume
App-based user controls: - World Volume
- Treble and bass (balance
adjustment) - Focus (mic directionality)
- Left/Right (balance
adjustment) - Modes (Bose-recommended
gain profiles, user-
customizable) - Bluetooth pairing with
hearing aids | The combined suite of on-device
and app-based user controls of
hearing aids are comparable
between the subject and predicate
devices.
The predicate device's "Focus"
feature is specific to the
microphone configuration of its
RIC/BTE form factor, which
benefits from the ability to change
directionality modes. The subject
device's CIC form factor utilizes an
omnidirectional microphone
configuration that sits within the ear
canal when inserted into the ear and
leverages the natural directional
characteristics of the head and
pinna during normal use.
Other differences in feature
implementation and adjustability do not
raise different questions of safety and
effectiveness. |
| Over The Air
(OTA)
Firmware
Update | The hearing aids automatically
update when connected to the mobile
app. The Eargo Mobile app allows
for remote firmware update of the
hearing aids. | The hearing aids automatically
update when connected to the mobile
app. | The firmware update process is the
same as predicate. |
| Feature/
Attribute | Eargo Self Fitting Hearing Aid
(Subject Device) | Bose SoundControlTM Hearing Aid
(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.
This difference does not raise different questions of safety and effectiveness.
Data from a clinical validation study support substantial equivalence. |
| Noise
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
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) | |
| Self-Fitting
Method | The Eargo Self-Fitting Hearing Aid
uses a proprietary method that
requires the user to complete a self-
guided hearing assessment using the
mobile app while wearing the
hearing aids. The hearing aids act as
the transducer, emitting tonal stimuli
of varying levels at different
audiometric frequencies. The
measured hearing thresholds are then
used as the basis for fitting the
appropriate gain profile(s) for the
user. Once fitted, the user can make
additional adjustments (e.g., volume,
bass/treble) to the left, right, or both
hearing aids to achieve a desired
fitting. | The predicate device utilizes a
proprietary fitting approach that does
not require determination of hearing
thresholds. Each user starts with the
same settings and adjusts settings
(e.g., volume, bass/treble, left/right
balance) based on the user's
preference and the listening
environment to achieve a
satisfactory fitting. | Both the subject and predicate devices
use proprietary fitting algorithms.
While the basis for self-fitting differ
in that the subject device uses an
approach based on hearing thresholds
and the predicate device uses an
approach based on user preference,
both are intended to provide adequate
fitting for individuals with perceived
mild to moderate hearing impairment.
Clinical and usability data
demonstrate that the subject device's
self-fitting approach is able to deliver
hearing aid output comparable to
NAL-NL2 prescription targets. Thus,
the subject device provides adequate
amplification for individuals with
mild to moderate hearing
impairment, just as the predicate device
does. |
8
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510(k) Notification Eargo Self-Fitting Hearing Aids
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Any differences in technological characteristics between the subject and predicate devices do not carry any impact to the subject device's intended use, and do not raise different questions of safety or effectiveness. Testing against common industry performance standards and demonstrated equivalence in functional performance testing indicate that the subject device is substantially equivalent to the predicate device for the same intended use.
-
SPECIAL CONTROLS
The Eargo Self-Fitting Hearing Aids conform to the special controls stated in 21 CFR 874.3325. The requirements are satisfied through: -
· Labeling
-
Performance testing .
-
Clinical data ●
-
Usability testing/human factors validation .
-
SELF-SELECTION LABELING ●
Self-Selection labeling mitigating the risk of improper self-selection has been included in the Quick Start User Guide and the Full-Length User Guide for Eargo Self-Fitting Hearing Aids. In summary, the self-selection labeling addresses:
- · Identifying situations in which the Eargo Self-Fitting Hearing Aids may help users hear better.
- Identifying situations in which the Eargo Self-Fitting Hearing Aids may not . be right for users.
- . Identifying criteria for which users should see a hearing professional.
- Informing users that Eargo Self-Fitting Hearing Aids will not restore normal ● hearing.
- . Informing users that it is good health practice to have hearing loss evaluated by an appropriate health care professional.
- PERFORMANCE TESTING .
See Table 2 & Table 3 below.
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Table 2: Safety Compliance Testing Summary
| Compliance / Testing Standard(s) / FDA Guidance | Test Purpose | Result |
|---|---|---|
| FCC Title 47 CFR, subpart 15 subpart C | ||
| Intentional Radiators | Basic Safety and | |
| Essential | ||
| Performance | Pass | |
| IEC 60601-1:2014 | ||
| Medical electrical equipment – Part 1: General | ||
| requirements for basic safety and essential performance | Basic Safety and | |
| Essential | ||
| Performance | Pass | |
| IEC 60601-2-66: 2019 Medical electrical equipment – | ||
| Part 2-66: Particular requirements for the basic safety | ||
| and essential performance of hearing instruments and | ||
| hearing instrument systems | Basic Safety and | |
| Essential | ||
| Performance | Pass | |
| IEC 60601-1-2:2014 | ||
| Medical electrical equipment – Part 1-2: General | ||
| requirements for basic safety and essential performance | ||
| – Collateral Standard: Electromagnetic disturbances – | ||
| Requirements and tests | Electromagnetic | |
| Compatibility | Pass | |
| IEC 60118-13:2019 | ||
| Electroacoustics - Hearing aids – Part 13: | ||
| Electromagnetic compatibility | Electromagnetic | |
| Compatibility | Pass | |
| ANSI ASA S3.22:2014 – Specification of Hearing Aid | ||
| Characteristics | Electroacoustics | |
| Performance | Pass | |
| • IEC 62304:2006 – Medical device software – | ||
| Software lifecycle processes | ||
| • FDA Guidance FDA-2020-D-0957 - Guidance for | ||
| the Content of Premarket Submissions for Software | ||
| Contained in Medical Devices, Guidance for | ||
| Industry and Food and Drug Administration Staff - | ||
| May 11, 2005 | Software | |
| Verification and | ||
| Validation | Pass | |
| Compliance / Testing Standard(s) / FDA Guidance | Test Purpose | Result |
| ISO 10993-1:2018 - Biological evaluation of | ||
| medical devices - Part 1: Evaluation and testing | ||
| within a risk management process ISO 10993-5:2009 - Biological evaluation of | ||
| medical devices - Part 5: Tests for in vitro | ||
| cytotoxicity ISO 10993-10:2010 - Biological evaluation of | ||
| medical devices – Part 10: Tests for irritation and | ||
| skin sensitization ISO 10993-12:2010 - Biological Evaluation of | ||
| Medical Devices – Part 12: Sample Preparation and | ||
| Reference Materials FDA Guidance FDA-2013-D-0350- Use of | ||
| International Standard ISO 10993-1, “Biological | ||
| evaluation of medical devices -- Part 1: Evaluation | ||
| and testing within a risk management process” - | ||
| September 4, 2020 | Biocompatibility | Pass |
| IEC 62366:2007 + A1:2014 – Medical devices – | ||
| Part 1: Application of usability engineering to | ||
| medical devices IEC 60601-1-6:2010 + A1:2013 - Medical electrical | ||
| equipment – Part 1-6: General requirements for | ||
| basic safety and essential performance - Collateral | ||
| standard: Usability FDA Guidance FDA-2011-D-0469 - Applying | ||
| Human Factors and Usability Engineering to Medical Devices, Guidance for | ||
| Industry and Food and Drug Administration Staff - | ||
| February 3, 2016 | Summative | |
| Usability / | ||
| Human Factors | ||
| Validation | Pass | |
| Compliance / Testing Standard(s) / FDA Guidance | Test Purpose | Result |
| FDA Guidance FDA-2018-D-3443 - Content of | ||
| Premarket Submissions for Management of | ||
| Cybersecurity in Medical Devices, Guidance for | ||
| Industry and Food and Drug Administration Staff - | ||
| October 18, 2018 FDA Guidance FDA-2015-D-5105 - Postmarket | ||
| Management of Cybersecurity in Medical Devices, | ||
| Guidance for Industry and Food and Drug | ||
| Administration Staff - December 28, 2016 | Cybersecurity | |
| Compliance | Pass | |
| ASTM D4169-16 Standard Practice for | ||
| Performance Testing of Shipping Containers and | ||
| Systems ASTM D7386-16 Standard Practice For | ||
| Performance Testing Of Packages For Single Parcel | ||
| Delivery Systems | Package and | |
| Transit Testing | Pass |
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Table 3: Electroacoustics Performance (ANSI/ASA S3.22 2014 Measurements or ANSI/CTA-2051:2017 where denoted by *)
| Characteristics | Eargo Self Fitting
Hearing Aids
(Subject Device) | Bose
SoundControl
Hearing Aid
(Predicate
Device) | Discussion |
|------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| OSPL 90 Curve | Image: Eargo Self Fitting Hearing Aids OSPL 90 Curve | Image: Bose SoundControl Hearing Aid OSPL 90 Curve | Comparable to predicate
device and suitable for
intended use. |
| MAX OSPL 90 | 106 dB SPL which is
less than 117 dB
SPL" | 113 dB SPL which
is less than 120 dB
SPL | Comparable to the predicate
device and less than
117 dBSPL per OTC hearing
aid requirements. |
| Characteristics | Eargo Self Fitting
Hearing Aids
(Subject Device) | Bose
SoundControl
Hearing Aid
(Predicate
Device) | Discussion |
| HFA OSPL 90 | 104 dBSPL | 106 dBSPL | Comparable to predicate
device and adequate for
fitting mild to moderate
hearing loss as prescribed by
NAL-NL2. |
| HFA FOG | 26 dB | 30 dB | Comparable to predicate
device and adequate for
fitting mild to moderate
hearing loss as prescribed by
NAL-NL2. |
| Reference Test
Gain (RTG) | 26 dB | 29 dB | Comparable to predicate
device and adequate for
fitting mild to moderate
hearing loss as prescribed by
NAL-NL2. |
| Frequency
Response | Image: Frequency response plot for Eargo Self Fitting Hearing Aids | Image: Frequency response plot for Bose SoundControl Hearing Aid | Comparable to predicate
device and suitable for
intended use. |
| Frequency
Range |