(191 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the Eargo Self-Fitting Hearing Aids, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly present a single "Table of Acceptance Criteria" with numerical targets and direct "Reported Device Performance" for each criterion in the same way one might find for a pass/fail mechanical test. Instead, the acceptance criteria are embedded within descriptions of various tests, and the "reported device performance" is the successful conclusion (e.g., "Pass," "Comparable to predicate," "Acceptable usability and satisfaction").
However, I can extract the implicit acceptance criteria and the demonstrated performance where quantitative or qualitative measures are reported:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and General Performance (Compliance with Standards) | |
| FCC Title 47 CFR, subpart 15 subpart C (Intentional Radiators) | Pass |
| IEC 60601-1:2014 (Basic Safety & Essential Performance) | Pass |
| IEC 60601-2-66:2019 (Basic Safety & Essential Performance for Hearing Instruments) | Pass |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility - EMC) | Pass |
| IEC 60118-13:2019 (Hearing Aid EMC) | Pass |
| ANSI ASA S3.22:2014 (Hearing Aid Characteristics - Electroacoustics) | Pass |
| IEC 62304:2006 (Software Lifecycle Processes) & FDA Guidance (Software Content of Premarket Submissions) | Pass (Software Verification and Validation) |
| ISO 10993-1, -5, -10, -12 (Biocompatibility) | Pass |
| IEC 62366:2007 + A1:2014 & IEC 60601-1-6:2010 + A1:2013 & FDA Guidance (Summative Usability / Human Factors Validation) | Pass |
| FDA Guidance (Cybersecurity Compliance) | Pass |
| ASTM D4169-16 & D7386-16 (Package & Transit Testing) | Pass |
| Electroacoustic Performance (Table 3) | |
| MAX OSPL 90 (less than 117 dB SPL per OTC HA requirements) | 106 dB SPL (less than 117 dB SPL) |
| HFA OSPL 90 (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 104 dBSPL (Comparable to predicate, adequate for NAL-NL2) |
| HFA FOG (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 26 dB (Comparable to predicate, adequate for NAL-NL2) |
| Reference Test Gain (RTG) (adequate for fitting mild-moderate HL as prescribed by NAL-NL2) | 26 dB (Comparable to predicate, adequate for NAL-NL2) |
| Frequency Range (suitable for intended use per OTC HA requirements) | <200 - 7500 Hz (Comparable to predicate and suitable) |
| Harmonic Distortion (%) (meets OTC HA requirements) | < 1% (Same as predicate, meets OTC HA requirements) |
| EIN (less than or equal to 32 dBSPL, comparable to predicate, meets OTC HA requirements) | < 30 dBSPL (Comparable to predicate, meets OTC HA requirements) |
| Latency (less than or equal to 15ms per OTC HA requirements) | 5.7ms (Comparable to predicate, meets OTC HA requirements) |
| Clinical Performance (Self-Fitting Accuracy and Effectiveness) | |
| Accuracy of Sound Match Hearing Thresholds (Statistical non-difference to Audiology Best Practice) | Pairwise t-test showed no statistically significant differences between EargoA (Sound Match in sound-treated booth) thresholds and clinical thresholds (ABP) at all frequencies. Test-retest reliability between EargoA and EargoB (Sound Match in quiet room) also showed no statistically significant differences. Mean SUS score of 71 (above industry benchmark of 68). |
| Effectiveness of Self-Fitting (Non-inferiority to Audiologist-Fit) in key outcome measures | |
| Real Ear Aided Response (REAR) (within 5 dB RMSE of NAL-NL2 targets at 250 Hz, 1 kHz, 2 kHz, 4 kHz, and no significant difference between self-fit and AUD-fit) | Average RMSE from NAL-NL2 targets were below 5 dB for both fitting conditions. No significant differences noted between real-ear gain measured between self-fit and AUD-fit settings (Figure 4). |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) (self-fit not inferior to AUD-fit; improved over unaided) | Very similar aided mean and standard deviation values for self-fit and AUD-fit across APHAB subscales and overall APHAB-global score. Mean scores significantly improved over the unaided condition for both self-fit and AUD-fit on EC, BN, RV subscales and global score (Figure 5). |
| Speech Intelligibility in Noise (self-fit similar to AUD-fit) | Very similar mean and standard deviation values when comparing aided speech in noise scores for self-fit and AUD-fit (Figure 6). |
| Subjective Sound Quality Ratings (self-fit similar to AUD-fit; acceptable in real-world usage) | Very similar mean and standard deviation scores when comparing overall sound quality ratings for self-fit and AUD-fit (Figure 7). Data from 255 survey respondents (real-world users) indicate that the device's subjective sound quality was acceptable. |
| Usability and Human Factors | |
| Real-World Fit and Comfort (acceptable ratings) | 88% rated "Good" or "Excellent" for fit; 94% rated "Never" or "1-2 times daily" for migration; 94% rated "Mild" or "No Discomfort" for discomfort (Table 4). |
| Real-World Safety (no observed device-related adverse events) | No health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed during unsupervised real-world device usage (ranging from 41 to 210 days). |
| Real-World Satisfaction and Usability (acceptable across assessed areas, including Sound Match, adjustments, sound quality, perceived benefit) | Responses from 255 subjects demonstrated acceptable usability and satisfaction in all assessed areas (Sound Match completion, device maintenance/cleaning, subjective sound quality, app-based adjustments, perceived benefit). |
| Human Factors Validation of Self-Fit Strategy (critical tasks completed successfully by at least 80% with no use errors) | 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. |
| Human Factors Validation of Device Labeling and Handling/Maintenance (critical tasks completed successfully and independently by at least 80%) | All six use case scenarios (Understanding outside/inside package labeling, Device charging, Eartip self-selection/replacement/insertion/removal, Mic cap replacement, Device cleaning) met the acceptance criteria of being completed successfully and independently by at least 80% of participants. A task was considered a failure if assistance was needed. |
Study Details:
2. Sample sizes used for the test set and the data provenance
-
Clinical Validation of Eargo's Sound Match Hearing Thresholds:
- Test Set Sample Size: 100 subjects (76 with hearing loss, 24 normal hearing).
- Data Provenance: Three geographically disparate U.S. sites (University of the Pacific - San Francisco and Stockton campuses). Data appears to be prospective, collected specifically for this validation.
-
Clinical Verification of Eargo's Self-Fitting Approach:
- Test Set Sample Size: 33 subjects.
- Data Provenance: Center for Applied and Translational Sensory Science at the University of Minnesota, U.S. Data appears to be prospective, collected specifically for this clinical trial.
-
Real-World Fit and Comfort / Real-World Safety:
- Test Set Sample Size: 33 participants for Fit/Comfort; 31 participants for Safety.
- Data Provenance: Real-world usage in the U.S. This appears to be prospective data collection.
-
Real-World Evaluation of Satisfaction and Usability:
- Test Set Sample Size: 255 subjects.
- Data Provenance: Web-based survey of adults in the U.S. who have used Eargo devices for at least two months. This appears to be retrospective (surveying existing users).
-
Human Factors Validation of Self-Fit Strategy:
- Test Set Sample Size: 16 participants.
- Data Provenance: U.S. setting for a summative usability test. This is prospective.
-
Human Factors Validation of Device Labeling and Device Handling/Maintenance:
- Test Set Sample Size: 24 participants.
- Data Provenance: U.S. setting for human factors validation testing. This is prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
-
Clinical Validation of Sound Match:
- Ground Truth: "Audiometric thresholds obtained by an Audiologist in a sound-treated booth, following Audiology best practice methods (ABP)."
- Experts: While the exact number of audiologists is not specified, it was conducted by "an Audiologist" (implying one per test administration) at the "University of the Pacific" which implies qualified personnel. The setup suggests multiple audiologists involved across the two campuses. Qualifications are implied by "Audiology best practice methods."
-
Clinical Verification of Self-Fitting Approach:
- Ground Truth: "Real Ear Aided Response (REAR) to NAL-NL2 targets... and other measures (APHAB, speech in noise, sound quality ratings) were compared against results from the same hearing aid fit by an audiologist following clinical best practice methods for fitting hearing aids."
- Experts: "a research audiologist" at the "University of Minnesota" for the AUD-fit condition. This implies a single, qualified audiologist for all AUD-fit programming in this trial. Further expertise is implicitly built into the NAL-NL2 prescription targets and clinical best practices.
-
Other studies (Usability, Safety, Satisfaction, Human Factors): Ground truth was established through participant feedback, observation of task completion, and adherence to established human factors methodologies rather than expert clinical interpretation of results. No external "experts" were explicitly mentioned for ground truth establishment beyond the study design and evaluation team.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe a formal adjudication method (like 2+1 or 3+1) for the clinical or human factors studies.
- Clinical Validation of Sound Match: Comparison was directly between two measurement methods (Eargo Sound Match vs. Audiologist Best Practice), with statistical analysis determining equivalence.
- Clinical Verification of Self-Fitting: Within-subject crossover design, comparing self-fit outcomes directly against audiologist-fit outcomes, with statistical analysis for non-inferiority/equivalence.
- Human Factors/Usability: Task success was observed and rated as successful, with difficulty, assistance, or failed/unable to complete. "No use errors" or "completed successfully by at least 80% of participants" were reported. The experimenter assisted only if asked, implying that "assistance" counted against independence.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No Multi-Reader Multi-Case (MRMC) study was done for AI assistance. This device is a self-fitting hearing aid, not an AI-assisted diagnostic tool for human readers. The studies compare a self-fitting method to a professionally-fitted method, both involving a human user (the patient) directly.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in the context of the device's self-fitting algorithm. The "Sound Match" feature is described as Eargo's "proprietary, app-based method for self-determining audiometric thresholds," where the "hearing aids act as the transducer, emitting tonal stimuli... The measured hearing thresholds are then used as the basis for fitting the appropriate gain profile(s)." This is the algorithm's direct measurement output.
- The "Clinical Validation of Eargo's Sound Match Hearing Thresholds" directly assesses the accuracy of this algorithm's output (EargoA/EargoB thresholds) against audiologist-derived thresholds (ABP). This is essentially a standalone evaluation of the algorithm's ability to measure hearing thresholds.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Clinical Validation of Sound Match: Expert Consensus / Standard of Care (audiometric thresholds measured by an audiologist following audiology best practice methods).
- Clinical Verification of Self-Fitting: Mixed ground truth:
- Objective: NAL-NL2 prescriptive targets for REAR (an established audiological fitting formula).
- Comparative Clinical Outcome: Audiologist-fit condition using clinical best practices for APHAB, speech in noise, and subjective sound quality.
- Usability/Human Factors: Observation of task completion based on pre-defined criteria, and user self-reported satisfaction/experience, aligned with established human factors validation methodologies.
8. The sample size for the training set
- The document does not provide specific information on the sample size for the training set used to develop the Eargo self-fitting algorithm or the Sound Match feature. It only describes the validation studies. The algorithm is described as "proprietary," indicating its development was internal to Eargo.
9. How the ground truth for the training set was established
- The document does not explicitly describe how the ground truth for the training set was established. Given the proprietary nature of the self-fitting algorithm and Sound Match, this information would likely be confidential commercial information not typically disclosed in a 510(k) summary. However, it can be inferred that its development would have been based on established audiology principles and data, similar to the validation methods, but applied to a development dataset.
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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 (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
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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: 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
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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/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 forUse | 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 incanal) form factor. Non-custom,separate left and right ear units. User-replaceable eartips come in differentsizes.Image: Eargo Self Fitting Hearing Aid | Traditional receiver in the canal(RIC) and behind the ear (BTE)form factor. Non-custom, separateleft and right ear units. User-replaceable eartips come in differentsizes. Factory replaceable wire cablecomes in different sizes.Image: Bose SoundControl Hearing Aid | The subject device form factor is awireless CIC and the predicatedevice form factor is a RIC/BTEwith wired earbuds, data frombiological safety testing, usabilitytesting, and clinical validation datasupport substantial equivalencewith the predicate device. |
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControlTM Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| WirelessCommunicationMobile app (viasmartphone/mobile device) tohearing aidsystem | Wireless communication between themobile app and the hearing aidsystem occurs in two ways:1) Mobile app to hearing aids:Wireless communication from themobile app to the hearing aids isdone via a proprietary EargoUltraSonic (EUS) communicationprotocol. App to hearing aidcommunication via EUS supportsSound Match self-fitting, andprogram and settings changes to thehearing aids.2) Mobile app to charger case:Wireless communication from themobile app to the charger case isdone via 2.4GHz Bluetooth 5.0 LowEnergy (BT5.0 LE). App to chargercase communication via BT5.0 LEsupports hearing aid programming,system info recognition by the app,and delivering firmware updates tothe hearing aid system. | Wireless communication betweenthe mobile app and the hearing aidsoccurs via the 2.4GHz BluetoothLow Energy (BLE) standard. App tohearing aid communication via BLEsupports self-fitting (i.e., listeningmode and settings changes) andfirmware updates. | Wireless (app-based) user controls ofthe subject device, such as self-fitting,program and setting changes etc. areachieved via EUS. Additional app-based user controls related toprogramming, recognizing, andupdating the hearing aids are facilitatedby a BT5.0 LE connection between theapp and the charger.The technological differences of thesubject device + mobile product/App(using EUS) versus the predicate +mobile device/its App (using BluetoothLE) are supported by usability testingof the subject device. This usabilitytesting demonstrated both usersatisfaction and ease of use for EUScontrol of the Eargo hearing aids.While the communication protocolsdiffer between the subject and predicatedevices, the overall wireless-supportedfunctions and connectivity/electricalsafety risks are similar and do not raisedifferent questions of device safety andeffectiveness. |
| Feature/Attribute | Eargo Self Fitting Hearing Aid(Subject Device) | Bose SoundControlTM Hearing Aid(Predicate Device) | Discussion |
| BluetoothPairing andControl | Pairing, control, and verification withthe paired mobile device are done viathe charger case. | Pairing, control, and verificationwith the paired mobile device aredone via the hearing aids. | While the pairing process differsbetween subject and predicate devices,they are using the same technology.These differences do not raise differentquestions of safety andeffectiveness. |
| Data from wireless performancetesting support substantialequivalence. | |||
| Feature/ | Eargo Self Fitting Hearing Aid | Bose SoundControl™ Hearing Aid | Discussion |
| Attribute | (Subject Device) | (Predicate Device) | |
| Battery | Eargo Self Fitting Hearing Aids arerechargeable, with the hearing aidscharged inside a proprietary portablecharger case via wireless (near-fieldinductive) charging.The charger case contains a Li-ionbattery that provides up to 3 hearingaid use cycles (for a pair of hearingaids) on a single full charge,depending on use. The charging casesupports both self-powered operationand/or being powered by a standardUSB-C cable connected to a powersupply. When connected to a USBpower supply, the internal battery isrecharged, allowing for subsequenton-the-go charging of hearing aids.Eargo hearing aids house a smallcapacity secondary type(rechargeable) Li-Ion battery that iscertified to IEC 62133-2:2017. Thebattery allows for up to 16 hours ofruntime, depending on use. | Bose SoundControl Hearing Aidsrequire single-use Size 312 primarytype (non-rechargeable) Zn-Airbatteries. | The subject device is rechargeablebetween use cycles, while thepredicate device uses replaceablebatteries. The differences in batterytype and capacity do not raisedifferent questions of safety oreffectiveness.Data from battery safety testingsupport substantialequivalence. |
| Feature/Attribute | Eargo Self Fitting Hearing Aid(Subject Device) | Bose SoundControlTM Hearing Aid(Predicate Device) | Discussion |
| Microphones | Subject device CIC hearing aids eachcontain a single omnidirectionalmicrophone to allow for acousticinput. | Predicate device BTE hearing aidscontain microphones that may,during use, be configured by the userin omnidirectional or directionalmodes. | The predicate device has a RIC/BTEform factor with two microphones thatcan be configured in omnidirectionalor directional modes.The subject device has a singleomnidirectional microphone notconfigurable by the user. The subjectdevice though is completely in canal(CIC) style hearing aid allowing theuser to use natural pinna cues fordirectionality.Clinical validation data supportsubstantial equivalence with the |
| predicate device. | |||
| Feature/Attribute | Eargo Self Fitting Hearing Aid(Subject Device) | Bose SoundControlTM Hearing Aid(Predicate Device) | Discussion |
| User/DeviceControls | On-device user controls:- User-selectable- Programs/Environments(i.e., Eargo-recommendedgain 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 withEargo Charger | On-device user controls:- Power on/off- World VolumeApp-based user controls:- World Volume- Treble and bass (balanceadjustment)- Focus (mic directionality)- Left/Right (balanceadjustment)- Modes (Bose-recommendedgain profiles, user-customizable)- Bluetooth pairing withhearing aids | The combined suite of on-deviceand app-based user controls ofhearing aids are comparablebetween the subject and predicatedevices.The predicate device's "Focus"feature is specific to themicrophone configuration of itsRIC/BTE form factor, whichbenefits from the ability to changedirectionality modes. The subjectdevice's CIC form factor utilizes anomnidirectional microphoneconfiguration that sits within the earcanal when inserted into the ear andleverages the natural directionalcharacteristics of the head andpinna during normal use.Other differences in featureimplementation and adjustability do notraise different questions of safety andeffectiveness. |
| Over The Air(OTA)FirmwareUpdate | The hearing aids automaticallyupdate when connected to the mobileapp. The Eargo Mobile app allowsfor remote firmware update of thehearing aids. | The hearing aids automaticallyupdate when connected to the mobileapp. | The firmware update process is thesame 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. |
| NoiseReduction | 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. |
| FeedbackCancellation | 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-FittingMethod | The Eargo Self-Fitting Hearing Aiduses a proprietary method thatrequires the user to complete a self-guided hearing assessment using themobile app while wearing thehearing aids. The hearing aids act asthe transducer, emitting tonal stimuliof varying levels at differentaudiometric frequencies. Themeasured hearing thresholds are thenused as the basis for fitting theappropriate gain profile(s) for theuser. Once fitted, the user can makeadditional adjustments (e.g., volume,bass/treble) to the left, right, or bothhearing aids to achieve a desiredfitting. | The predicate device utilizes aproprietary fitting approach that doesnot require determination of hearingthresholds. Each user starts with thesame settings and adjusts settings(e.g., volume, bass/treble, left/rightbalance) based on the user'spreference and the listeningenvironment to achieve asatisfactory fitting. | Both the subject and predicate devicesuse proprietary fitting algorithms.While the basis for self-fitting differin that the subject device uses anapproach based on hearing thresholdsand the predicate device uses anapproach based on user preference,both are intended to provide adequatefitting for individuals with perceivedmild to moderate hearing impairment.Clinical and usability datademonstrate that the subject device'sself-fitting approach is able to deliverhearing aid output comparable toNAL-NL2 prescription targets. Thus,the subject device provides adequateamplification for individuals withmild to moderate hearingimpairment, just as the predicate devicedoes. |
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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 CIntentional Radiators | Basic Safety andEssentialPerformance | Pass |
| IEC 60601-1:2014Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance | Basic Safety andEssentialPerformance | Pass |
| IEC 60601-2-66: 2019 Medical electrical equipment –Part 2-66: Particular requirements for the basic safetyand essential performance of hearing instruments andhearing instrument systems | Basic Safety andEssentialPerformance | Pass |
| IEC 60601-1-2:2014Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performance– Collateral Standard: Electromagnetic disturbances –Requirements and tests | ElectromagneticCompatibility | Pass |
| IEC 60118-13:2019Electroacoustics - Hearing aids – Part 13:Electromagnetic compatibility | ElectromagneticCompatibility | Pass |
| ANSI ASA S3.22:2014 – Specification of Hearing AidCharacteristics | ElectroacousticsPerformance | Pass |
| • IEC 62304:2006 – Medical device software –Software lifecycle processes• FDA Guidance FDA-2020-D-0957 - Guidance forthe Content of Premarket Submissions for SoftwareContained in Medical Devices, Guidance forIndustry and Food and Drug Administration Staff -May 11, 2005 | SoftwareVerification andValidation | Pass |
| Compliance / Testing Standard(s) / FDA Guidance | Test Purpose | Result |
| ISO 10993-1:2018 - Biological evaluation ofmedical devices - Part 1: Evaluation and testingwithin a risk management process ISO 10993-5:2009 - Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity ISO 10993-10:2010 - Biological evaluation ofmedical devices – Part 10: Tests for irritation andskin sensitization ISO 10993-12:2010 - Biological Evaluation ofMedical Devices – Part 12: Sample Preparation andReference Materials FDA Guidance FDA-2013-D-0350- Use ofInternational Standard ISO 10993-1, “Biologicalevaluation of medical devices -- Part 1: Evaluationand testing within a risk management process” -September 4, 2020 | Biocompatibility | Pass |
| IEC 62366:2007 + A1:2014 – Medical devices –Part 1: Application of usability engineering tomedical devices IEC 60601-1-6:2010 + A1:2013 - Medical electricalequipment – Part 1-6: General requirements forbasic safety and essential performance - Collateralstandard: Usability FDA Guidance FDA-2011-D-0469 - ApplyingHuman Factors and Usability Engineering to Medical Devices, Guidance forIndustry and Food and Drug Administration Staff -February 3, 2016 | SummativeUsability /Human FactorsValidation | Pass |
| Compliance / Testing Standard(s) / FDA Guidance | Test Purpose | Result |
| FDA Guidance FDA-2018-D-3443 - Content ofPremarket Submissions for Management ofCybersecurity in Medical Devices, Guidance forIndustry and Food and Drug Administration Staff -October 18, 2018 FDA Guidance FDA-2015-D-5105 - PostmarketManagement of Cybersecurity in Medical Devices,Guidance for Industry and Food and DrugAdministration Staff - December 28, 2016 | CybersecurityCompliance | Pass |
| ASTM D4169-16 Standard Practice forPerformance Testing of Shipping Containers andSystems ASTM D7386-16 Standard Practice ForPerformance Testing Of Packages For Single ParcelDelivery Systems | Package andTransit 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 FittingHearing Aids(Subject Device) | BoseSoundControlHearing Aid(PredicateDevice) | Discussion |
|---|---|---|---|
| OSPL 90 Curve | Image: Eargo Self Fitting Hearing Aids OSPL 90 Curve | Image: Bose SoundControl Hearing Aid OSPL 90 Curve | Comparable to predicatedevice and suitable forintended use. |
| MAX OSPL 90 | 106 dB SPL which isless than 117 dBSPL" | 113 dB SPL whichis less than 120 dBSPL | Comparable to the predicatedevice and less than117 dBSPL per OTC hearingaid requirements. |
| Characteristics | Eargo Self FittingHearing Aids(Subject Device) | BoseSoundControlHearing Aid(PredicateDevice) | Discussion |
| HFA OSPL 90 | 104 dBSPL | 106 dBSPL | Comparable to predicatedevice and adequate forfitting mild to moderatehearing loss as prescribed byNAL-NL2. |
| HFA FOG | 26 dB | 30 dB | Comparable to predicatedevice and adequate forfitting mild to moderatehearing loss as prescribed byNAL-NL2. |
| Reference TestGain (RTG) | 26 dB | 29 dB | Comparable to predicatedevice and adequate forfitting mild to moderatehearing loss as prescribed byNAL-NL2. |
| FrequencyResponse | Image: Frequency response plot for Eargo Self Fitting Hearing Aids | Image: Frequency response plot for Bose SoundControl Hearing Aid | Comparable to predicatedevice and suitable forintended use. |
| FrequencyRange | <200 - 7500 Hz | <200-8000 Hz | Comparable to predicate andsuitable for intended use perOTC hearing aidrequirements. |
| HarmonicDistortion (%) | < 1% | < 1% | Same as the predicate deviceand per OTC hearing aidrequirements. |
| EIN | < 30 dBSPL | <27 dBSPL | Less than or equal to 32dBSPL. Comparable topredicate device and perOTC hearing aidrequirements. |
| Characteristics | Eargo Self FittingHearing Aids(Subject Device) | BoseSoundControlHearing Aid(PredicateDevice) | Discussion |
| Battery Current | 0.56mA | 2.8mA | Eargo Self-Fitting HearingAids use a customrechargeable li-ion battery,whereas the predicate deviceuses replaceable zincbatteries. |
| Latency* | 5.7ms | 5.5ms | Comparable to predicatedevice and less than or equalto 15ms per OTC hearing aidrequirements. |
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• CLINICAL DATA
Clinical studies across three geographically disparate U.S sites were conducted to validate the self-fitting strategy of the Eargo Self-Fitting Hearing Aid. The studies focused on 1) validating the accuracy of audiometric thresholds measured with Eargo's Sound Match feature against the audiometric thresholds measured by an audiologist following audiology best practice methods, and 2) validating the effectiveness of Eargo's self-fitting approach in a clinical trial comparing self-fitting hearing aid outcomes to the same hearing aid fit by an audiologist following clinical best practice methods for fitting hearing aids. Outcome measures - comparing the two fitting methods - included: subjective hearing aid benefit with in-field device wear, real-ear aided response, lab-based measures of subjective sound quality, and speech intelligibility in noise.
Finally, Eargo also administered a sound quality satisfaction survey to hearing impaired individuals who have used Eargo devices (hearing aids and the mobile-app) in the field (i.e., real-world situations) for two months or longer.
Clinical Validation of Eargo's Sound Match Hearing Thresholds Against Audiology Best Practice
To validate the accuracy of Sound Match. Eargo's proprietary, app-based method for selfdetermining audiometric thresholds, Eargo collaborated with the University of the Pacific (San Francisco and Stockton campuses) to conduct a study involving hearing impaired and normal hearing subjects. One hundred subjects (76 with hearing loss), 18 years of age or
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older, participated in the study. Subjects varied in age (ranging from 22 - 99 years), gender (52 female and 48 male) and degree of hearing loss.
Subjects were tested across three conditions: 1) air-conduction audiometric thresholds obtained by an Audiologist in a sound-treated booth, following Audiology best practice methods (ABP), and 2) subject-determined air-conduction audiometric thresholds using Eargo Sound Match in a sound-treated booth (EargoA) and 3) in a quiet room (EargoB). 100 subjects completed the ABP and EargoA conditions, and 91 subjects completed the EargoB condition. Overall, EargoA thresholds were comparable to ABP across all frequencies tested (Figure 2 - Panel A). 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 (Figure 2 - Panel B). Pairwise t-test showed no statistically significant differences between EargoA and EargoB thresholds.
Figure 2: Comparing audiometric thresholds measured with Sound Match vs Audiology Best Practice. Panel A - Comparing averaged thresholds (across both ears and all the subjects) measured at different frequencies between EargoA (in red) and ABP (in black). Panel B - Comparing averaged thresholds (across both ears and all the subjects) measured at different frequencies between EargoA (in red) and EargoB (in blue).
Image /page/22/Figure/5 description: The image contains two line graphs comparing audiometric thresholds. The graph on the left, labeled 'A', compares 'EargoA' and 'ABP', showing thresholds decreasing from around 30 dB HL at 500 Hz to approximately 42 dB HL at 4000 Hz. The graph on the right, labeled 'B', assesses 'Test-Retest Reliability' between 'EargoA' and 'EargoB', with both showing similar thresholds around 28 dB HL at 500 Hz, decreasing to about 45 dB HL at 4000 Hz.
Eargo Sound Match was also evaluated with the System Usability Scale (SUS), and the mean overall SUS score was 71, which compares favorably to the industry benchmark of 68. This suggests that subjects were able to easily and independently self-measure audiometric thresholds using Eargo's Sound Match feature.
These results strongly suggest that audiometric thresholds self-measured by subjects using Eargo's Sound Match feature are comparable to the air-conduction hearing thresholds
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measured by Audiologists following audiology standard of care, and therefore can be an effective basis for self-fitting.
Clinical Verification of Eargo's Self-Fitting Approach
A clinical trial was conducted at the Center for Applied and Translational Sensory Science at the University of Minnesota to validate Eargo's self-fitting approach. 33 subjects (18 female, 15 male), aged between 24 to 83 years, with predominantly mild-to-moderate hearing loss in both ears participated in the study. 14 subjects had prior experience with hearing aid use. Inclusion criteria for participation included sensorineural hearing loss in both ears from .25-4 kHz, with the cutoff threshold of 65 dB at these frequencies. Mean audiograms for left and right ears for the 33 participants are shown in Figure 3.
Image /page/23/Figure/5 description: The image is a title for a figure. The title states, "Figure 3: Mean audiometric thresholds for 33 participants for left and right ears." The title describes the contents of the figure.
Image /page/23/Figure/6 description: The figure is a clinical audiogram showing hearing thresholds for the left and right ears across different frequencies. The x-axis represents frequency in Hertz (Hz), ranging from 250 to 8000 Hz, while the y-axis represents hearing level in decibels (dB HL), ranging from 0 to 90 dB. The graph shows that hearing thresholds increase (hearing worsens) as frequency increases for both ears. The left ear is represented by a line with error bars and plus symbols, while the right ear is represented by a line with error bars and circles.
Each participant completed 3 separate testing visits. A within-subject, crossover design in which all participants completed both field trial hearing aid fitting conditions (self-fit and audiologist-fit hearing aids) was used. The order of the field trials was randomized across participants to account for any potential order effects. After each field trial, participants visited the lab to complete study outcome measures. The participants wore devices for each fitting condition for 2-3 weeks in the field and were blinded to the fitting approach. At the initial visit, the participants completed a standard clinical hearing test as well as selfmeasured their hearing thresholds using Eargo's Sound Match feature. Consistent with the results shown in Figure 2, no significant differences were noted between thresholds measured using the clinical best practice methods and Eargo's Sound Match feature.
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In the 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. All programming changes were made using Eargo Fitting Software. Participants were given the option to make requests for further adjustments based on subjective complaints. REAR was recorded after adjustments. In the self-fit condition, the thresholds measured using Eargo's Sound Match feature were first mapped to an audiogram from a pre-populated list. Hearing aid fitting parameters (based on a proprietary fitting formula) were loaded into the devices based on the measured thresholds. Participants were given the option to self-adjust the treble, bass, and overall volume of the hearing aids using the accompanying Eargo app. REAR measurement was recorded after the participants made adjustments using the app. All real-ear measures were recorded using the International Speech Test Signal (ISTS) at 65 dB SPL. No significant differences were noted between real-ear gain measured between self-fit and AUD-fit settings, as shown in Figure 4. 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. An RMSE criterion of 5dB from prescriptive targets has been the precedent in academic research and is attainable for most mild to severe hearing losses.
Figure 4: Mean REAR comparisons between the fitting approaches. Comparison of average self-fit and AUD-fit for a 65-dB SPL male talker. Mean and standard deviations are shown for 33 participants.
Image /page/24/Figure/4 description: The image is a graph titled "Real Ear Measure: AUD Fit vs SELF Fit". The x-axis is labeled "Frequency (Hz)" and ranges from 250 to 4000. The y-axis is labeled "Output (dB SPL)" and ranges from 20 to 90. There are three lines on the graph, labeled "NAL-NL2 TGT", "AUD FIT", and "SELF FIT".
All participants completed the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire2. The objective of the APHAB measure was to confirm that performance outcomes for the self-fit condition were not inferior to those from the same devices fit by an audiologist (AUD-fit) after a period of hearing-aid use in everyday listening conditions. The primary endpoint was the APHAB-global score. Participants completed the questionnaire at the time of recruitment (unaided) and following each of the two field
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trial conditions (self-fit and AUD-fit). Results showed 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 (see Figure 5). On all three subscales assessing speech communication (Ease of Communication - EC, Background Noise - BN and Reverberation - RV) and the global score, mean scores were significantly improved over the unaided condition for both self-fit and AUD-fit. Overall, the APHAB results from this study are in agreement with those reported for the Bose predicate device study 3.
Figure 5: Raw APHAB scores for unaided, self-fit and AUD fit. Mean and standard error bars are shown for 33 participants.
Image /page/25/Figure/4 description: The image is a bar graph titled "APHAB Score Comparisons". The x-axis shows the categories Global, EC, BN, RV, and AV. The y-axis shows the APHAB scores from 0 to 80. The graph compares the scores for Unaided, AUD Fit, and Self Fit in each category, with Unaided generally having the highest scores.
Another primary endpoint, aided speech in noise understanding was measured using AZBio sentences in a sound treated booth for both AUD-fit and self-fit conditions. The speech was presented at 65 dB A and pink noise was presented at 60 dB A (+5 dB SNR). Results were scored as a percentage of words correct. Figure 6 shows speech recognition in noise scores for self-fit and AUD fit. Results showed very similar mean and standard deviation values when comparing the aided speech in noise scores for the two fitting approaches.
Figure 6: Aided speech recognition in noise scores for self-fit and AUD fit. Mean and standard deviations are shown for 33 participants.
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Image /page/26/Figure/2 description: The image is a bar graph titled "Speech in Noise Intelligibility". The y-axis is labeled "Percent Correct" and ranges from 0 to 100. There are two bars, one labeled "AUD" which is white and has a value of approximately 88, and one labeled "SELF" which is black and has a value of approximately 87.
A secondary endpoint measure, subjective sound quality ratings were completed after each field trial with the hearing aids. Participants rated the sound quality of 4 different stimuli using a sliding scale on a tablet while in a sound treated booth. Stimuli consisted of instrumental music, a female talker, a male talker, and a movie trailer. Figure 7 shows sound quality ratings for self-fit (black bars) and AUD-fit (open bars) conditions. Results showed very similar mean and standard deviation scores when comparing the overall sound quality ratings for the two fitting approaches.
Figure 7: Sound Quality Ratings self-fit and AUD fit. Mean and standard deviations are shown for 33 participants.
Image /page/26/Figure/5 description: The image is a bar graph titled "Subjective Sound Quality Comparisons". The y-axis is labeled "Sound Quality Rating" and ranges from 0 to 12. The x-axis shows five categories: Music, Female, Male, Movie, and Overall. For each category, there are two bars, one representing "AUD Fit" and the other representing "Self Fit", with the "Self Fit" bar generally having a higher rating than the "AUD Fit" bar.
Eargo also administered a sound quality satisfaction survey to hearing impaired individuals who have used Eargo devices (hearing aids and the Eargo mobile app) in the field (i.e., real-world situations) for two months or longer. The Eargo app allowed the users to adjust treble, bass, overall volume, and noise reduction settings amongst other
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things. 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. Data from 255 survey respondents indicate that the device's subjective sound quality was acceptable.
References
1 Keidser G, Dillon H, Flax T, et al. (2011). The NAL-NL2 prescription procedure. Audiol Research.
2 Cox R. Alexander G. (1995). The Abbreviated Profile of Hearing Aid Benefit (APHAB). Ear Hear 16: 176-186.
3 Sabin A. Van Tasell B. Rabinowitz B. Dhar S (2020). Validation of a self-fitting method for over-the-counter hearing aids. Trends in Hearing 24: 2331216519900589.
- · USABILITY/HUMAN FACTORS
The usability of the Eargo Self-Fitting Hearing Aid system was evaluated with respect to physical fit (the comfort and fit of the hearing aids) and safety during real-world use, general usability and satisfaction following real-world use, and human factors of Eargo's self-fitting functionality, device labeling, and device handling and maintenance,
Real-World Evaluation of Fit and Comfort
To evaluate the fit, migration, and comfort (FMC) of the Eargo Self-Fitting Hearing Aids, Eargo conducted a long-term, real-world usability study. The scope of testing assessed the fit and comfort characteristics of the hearing aid system (i.e., the hearing aids and charger) in a real-world use setting and was not focused on the system's self-fit capabilities (e.g., app-based self-fitting procedure).
Thirty-three participants with hearing impairment were provisioned with pre-production hearing aids, explained on its functionality and usage, assisted with its fit and eartip style and size selection, and instructed to wear the hearing aids in everyday settings. After at least two weeks of wear time, experimenters contacted participants and collected feedback related to overall fit, migration tendency (unwanted/unintended movement during wear), and level of comfort. Because the study was focused on fit and comfort, participants were not introduced to the companion Eargo mobile app.
All 33 study participants provided feedback regarding the fit and comfort of the hearing aids. Participants provided feedback on the overall FMC characteristics of the Eargo 5 hearing aids following 2 weeks (or longer) of daily wear. The results are shown in Table 4.
Table 4: Fit, Migration, Comfort of Eargo 5 Hearing Aids
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| Question | Response |
|---|---|
| Describe the fit of the device in your ear. | 88% rated "Good" or "Excellent" |
| On average, how many times per day dothe devices move (migrate) out of yourear? | 94% rated "Never" or "1-2 times daily" |
| Do you experience any discomfort whilewearing the devices? | 94% rated "Mild" or "No Discomfort" |
These results demonstrate that most participants found the subject device hearing aid form factor (and the included ear tips) to be acceptable in terms of fit and comfort in real-world use conditions.
Real-World Evaluation of Safety
To evaluate safety of the Eargo Self-Fitting Hearing Aids, Eargo conducted a long-term, real-world usability study. The scope of testing assessed the incidence of device-related adverse events during real-world use of the hearing aid system (i.e., the hearing aids and charger) and was not focused on the system's self-fit capabilities (e.g., app-based selffitting procedure).
In the real-world usability study, 31 participants with hearing impairment were provisioned with production-equivalent hearing aids, explained on its functionality and usage, assisted with its fit and eartip style and size selection, and instructed to wear the hearing aids in everyday settings. Participants wore the devices under real-world conditions for at least one month. During this unsupervised real-world device usage period, participants were instructed to report any device-related issues or health-/safety-related concerns to the experimenters immediately if and when such issues occurred. At the end of the study, experimenters made note of any device-related issues that were mentioned, including any issues that carried medical or safety concerns.
The companion Eargo mobile app was not included in these investigations as these studies focused only on the general use of the hearing aids.
Through the end of the observation period (ranging from 41 days to 210 days, depending on the participant), no health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed. These results suggest that the subject device hearing aids are safe for its intended users.
Real-World Evaluation of Satisfaction and Usability
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To evaluate general usability and satisfaction with the Eargo Self-Fitting Hearing Aids, Eargo conducted a real-world survey study. The scope of testing assessed the general usability and satisfaction with the devices (including using the companion Eargo mobile app to make adjustments), satisfaction with subjective sound quality during real-world situations, and perceived benefit from using the devices.
A web-based survey was administered to adult subjects with self-reported hearing impairment, who have used Eargo Self-Fitting Hearing Aids for at least two months, and who have completed the Sound Match self-fitting procedure using the companion mobile app.
Responses from 255 subjects meeting the inclusion criteria above demonstrated acceptable usability and satisfaction in all assessed areas. Specifically, system usability pertaining to Sound Match completion, device maintenance and cleaning procedures, satisfaction with subjective sound quality across a variety of real-world situations/environments, usability of and satisfaction with app-based device adjustments, and perceived benefit - all demonstrated acceptable usability and user satisfaction.
Human Factors Validation of Self-Fit Strategy
To assess the overall usability and intuitiveness of the self-fitting approach, Eargo conducted a human factors validation test (summative usability test) of Eargo Self-Fitting Hearing Aids. The scope of testing focused on the human factors associated with various use case scenarios related to self-fitting and was not focused on assessing the accuracy of self-fitting or perceived benefit of the Eargo Self-Fitting Hearing Aids.
The human factors validation of Eargo Self-Fitting Hearing Aids included 16 participants (11 male, 5 female) ranging from 22-95 years in age (mean: 55 years). The sample population was naive to the app-based self-fitting function of the Eargo Self-Fitting Hearing Aids and balanced with respect to perceived mild to moderate hearing impairment (8 with perceived impairment, 8 without).
Participants performed four, hands-on use case scenarios related to the self-fit procedure, each with action-based or knowledge-based tasks embedded within the scenarios. The scenarios assessed the user's experience in completing Sound Match, using the Eargo mobile app to make program and setting changes to the hearing aids, making in-situ program changes to the hearing aids without using the mobile app, and understanding the process of resetting hearing aids back to factory default settings. The specific use cases are described in Table 5.
For each use case scenario, one or more critical tasks were identified, such that their incorrect or incomplete performance may result in an improper self-fitting. Three critical tasks were identified for completing Sound Match, two critical tasks for using the mobile
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app to make program and setting changes, and one critical task each for making in-situ program changes and reverting the hearing aids back to factory default settings.
During the completion of each use case scenario, experimenters observed and rated whether each task within the scenario was completed successfully, completed with difficulty, completed with assistance, or failed (or unable) to complete (i.e., use error). Participants were instructed to complete each scenario on their own and ask for assistance when they felt it was required. The experimenter did not assist unless asked.
All four use case scenarios 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.
| Use Case Scenario | Result |
|---|---|
| Completing Sound Match | PASS |
| Using mobile app to change programs/settings | PASS |
| Making in-situ program changes without mobile app | PASS |
| Reverting settings back to factory defaults | PASS |
Table 5: Summary of Self-Fitting Use Case Scenario Results.
The use case scenarios related to completing Sound Match, using the mobile app to make program and setting changes. making in-situ program changes without the mobile app, and reverting hearing aids back to factory defaults were all completed with a high rate of success. The results demonstrate that the tasks (including critical tasks) required to complete each use case scenario were easy to complete by naive participants.
Human Factors Validation of Device Labeling and Device Handling/Maintenance
To assess the general usability and self-selection of the Eargo Self-Fitting Hearing Aids in intended use conditions (i.e., "intended for use without the assistance of a hearing care professional."), Eargo conducted a human factors validation test on the device's labeling, self-selection, and handling and maintenance procedures. The scope of testing focused on the human factors associated with use case scenarios related to label understanding, device self-selection, and general device handling and maintenance, completed only with relevant retail-equivalent instructional information, and without any assistance from the experimenters. The scope of this testing was not focused on assessing the accuracy of self-fitting or perceived benefit of the Eargo Self-Fitting Hearing Aids, nor on the general usability of the companion Eargo mobile app.
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The human factors validation testing included 24 participants (15 male, 9 female, 1 other) with self-reported hearing impairment (mean HHIE-S: 17.5), ranging from 26-78 years in age (mean: 47 years). The sample population was naive to the Eargo Self-Fitting Hearing Aids.
Participants performed two knowledge-based use case scenarios related to device labeling and four hands-on use case scenarios related to device handling and maintenance using only the relevant retail-equivalent instructional content, without any assistance from the experimenters. The knowledge-based scenarios assessed the user's understanding of device indications, warnings, and cautions, while the task-based scenarios assessed the user's experience in device charging, eartip self-selection, device insertion and removal, device maintenance, and device cleaning. The specific use cases are described in Table 6.
Table 6. Summary of Device Labeling and Handling/Maintenance Use Case Scenario Results.
| Use Case Scenario | Result |
|---|---|
| Understanding of outside the package devicelabeling (Indications and Warnings) | PASS |
| Understanding/acknowledgement of inside thepackage device labeling (Cautions, device useexpectations) | PASS |
| Device charging | PASS |
| Eartip self-selection, replacement, and deviceinsertion/removal | PASS |
| Mic cap replacement | PASS |
| Device cleaning | PASS |
For each use case scenario, one or more critical tasks were identified, such that their incorrect or incomplete performance may result in improper device usage. One critical task was identified for understanding device indications and warnings, one critical task for understanding cautions and device use expectations, one critical task for device charging, two critical tasks for eartip selection and device insertion, and one critical task for device cleaning.
During the completion of each use case scenario, experimenters observed and rated whether each task within the scenario was completed successfully, completed with difficulty, completed with assistance, or failed (or unable) to complete. For each scenario, participants were provisioned with the relevant instructions for use information and
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instructed to complete each scenario on their own. Given that the objective of the testing was to evaluate device interactions in intended use conditions, a task was considered a failure if the subject needed to ask the experimenter for assistance. All six use case scenarios met the acceptance criteria of being completed successfully and independently by at least 80% of participants.
- · SUMMARY
The Eargo Self-Fitting Hearing Aid has the same intended use as the predicate device, the Bose SoundControl™ Hearing Aid (K211008). As with the predicate device, the subject device is a self-fitting air-conduction hearing aid that incorporates wireless technology, intended for over the-counter sale to individuals 18 years or older with perceived mild to moderate hearing impairment. The subject device has been verified and validated per the same standards and guidelines as the predicate device. Clinical data demonstrate Eargo Self-Fitting Hearing Aid's ability to measure air-conduction hearing thresholds as accurately as audiology standard of care and deliver adequate amplification to meet widely accepted clinical prescription targets for mild to moderate hearing loss. The evidence from the clinical validation study provided strong support for the conclusion that the Eargo selffitting hearing aid has a reliable self-fitting method and will provide the intended population of adults (with perceived mild to moderate hearing loss) with functional performance that is not inferior to that provided by a professional hearing aid fitting. The findings of this clinical trial are similar to those from the Bose predicate device study (K211008). In addition, the system usability was rated as highly satisfactory.
Additional clinical data demonstrate the effectiveness of Eargo Self-Fitting Hearing Aid's acoustic performance, safety, general usability, user satisfaction, and its comparability to the predicate device. Data related to biocompatibility, electrical safety, electromagnetic compatibility, wireless communication, and electroacoustics support substantial equivalence to the predicate device with respect to safety. Differences in technological characteristics from the predicate device, such as CIC form factor and rechargeability, do not raise different questions of safety or effectiveness.
Taken together, the results from clinical studies, and usability studies demonstrate the effectiveness of the subject device's self-fitting strategy for its intended use, including its app-based measurement of hearing thresholds, ability to deliver appropriate amplification to its intended user, acceptable sound quality, ease of wear and self-fitting process, and safety. Thus, the clinical and non-clinical performance data demonstrate that the Eargo Self-Fitting Hearing Aid is substantially equivalent to the predicate device.
§ 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.