Sontro® OTC Hearing Aids (AI)

K231550 · Soundwave Hearing, LLC · QUH · Oct 26, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K231550
• Device Name: Sontro® OTC Hearing Aids (AI)
• Applicant: Soundwave Hearing, LLC
• Product Code: QUH · Ear, Nose, Throat
• Decision Date: Oct 26, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3325
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.

Device Story

Sontro® OTC Hearing Aids are self-fitting, wireless, air-conduction hearing aids; receiver-in-canal (RIC) form factor. Input: ambient audio via microphones. Processing: 16-channel wideband dynamic range compression; NAL-NL2 fitting algorithm; active noise reduction; feedback cancellation. Output: amplified sound delivered via receiver and ear domes. Operation: user-controlled via onboard buttons or otoTune® app (iOS/Android). Context: home/point-of-care; patient self-use. Benefit: compensates for mild-to-moderate hearing impairment; allows independent customization of gain/settings via in-situ testing.

Clinical Evidence

Clinical study (n=29) compared self-fitting (SELF-FIT) vs. clinician-fitting (CLINIC-FIT). Primary endpoints: Real-Ear Aided Response (REAR) and Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary: QuickSIN speech-in-noise performance. Results: SELF-FIT was non-inferior to CLINIC-FIT for REAR (95% CI: -0.44, 0.78 dB), APHAB global scores (95% CI: -4.35, 8.21), and QuickSIN SNR-loss (95% CI: -1.47, 1.36 dB). No adverse events reported.

Technological Characteristics

RIC form factor; 312 zinc-air battery; 16-channel wideband dynamic range compression; 2.4 GHz Bluetooth/BLE; NAL-NL2 fitting algorithm. Standards: IEC 60601-1, IEC 60601-2-66, IEC 60601-1-2, ANSI/ASA S3.22-2014, ANSI/CTA 2051-2017, ISO 14971, IEC 62366-1, IEC 62304.

Indications for Use

Indicated for individuals 18 years of age or older with perceived mild to moderate hearing impairment. Adjusted by the user to meet hearing needs without professional assistance.

Regulatory Classification

Identification

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

Special Controls

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

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

Predicate Devices

• Bose SoundControl Hearing Aid (K211008)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 26, 2023

% Kyle Rose CEO, Rook Quality Systems Rook Quality Systems, Inc. 1155 Mount Vernon Highway, Suite 800 Dunwoody, Georgia 30338

Re: K231550

Trade/Device Name: Sontro® OTC Hearing Aids (AI) Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: September 26, 2023 Received: September 27, 2023

Dear Kyle Rose:

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 (the Act) that do not require appro val 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shuchen Peng -S 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 Ouality Center for Devices and Radiological Health

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### Indications for Use

See PRA Statement below.

510(k) Number (if known) K2311550

Device Name Sontro® OTC Hearing Aids

Indications for Use (Describe)

The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. The device is intended for use 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) | <span style="padding-left:20px"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--|----------------------------------------------|-------------------------------------------------------------------------------------|
| | | |

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### 510 K Summary K231550

| Preparation Date: | September 21, 2023 |
|-------------------|--------------------|
|-------------------|--------------------|

**Applicant Name and Address**

| Company Name: | Soundwave Hearing, LLC |
|---------------|---------------------------------------------------------|
| Address: | 619 Enterprise Drive, Suite #205<br>Oak Brook, IL 60523 |

**Official Contact:**

| | Anthony Florek |
|------------|--------------------------------------------------------------------------|
| | President & Founder, Soundwave Hearing, LLC |
| Telephone: | 708-205-7998 |
| Email: | <a href="mailto:[e-mail]">[e-mail]</a> |

**Representative/Consultant**

| Company: | Rook Quality Systems |
|----------|--------------------------------------------------------|
| Address: | 1155 Mount Vernon Hwy, Suite 800<br>Dunwoody, GA 30338 |

| Contact: | Kyle Rose |
|------------|----------------------------------------------------------------|
| Telephone: | 404-717-9358 |
| Email: | <a href="mailto:[e-mail]">[e-mail]</a> |

# Current Device Information

| Trade/Proprietary Name | Sontro® Self-Fitting OTC Hearing Aids |
|------------------------|------------------------------------------------------------------------|
| Common Device Name | Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the-<br>Counter |
| Classification Name | Self-Fitting Wireless Air-Conduction Hearing Aid, Over-the-<br>Counter |
| Regulation Number | 21 CFR 874.3325 |
| Product Code(s) | QUH |
| Classification | Class II |
| Review Panel | Ear, Nose, and Throat Devices |
| Predicate Device | Bose SoundControl Hearing Aid (K211008) |
| Use | Over-the-Counter (OTC) |

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# 1. Device Description

Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. This is an over-the-counter hearing aid.

The Soundwave Hearing, Sontro® OTC (over-the-counter) Hearing Aids are self-fitting wireless air conduction hearing aids consisting of the hardware and software: the device uses the otoTune® app and accessories supplied in the carton. Each hearing aid in the pair functions and interacts with the otoTune® app independently and as a system.

A disposable size 312 zinc-air battery powers the hearing aids. The hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver in the canal that can be coupled with ear domes. The hearing aids are controlled via onboard button controls and wirelessly via the otoTune® app (iOS and Android). The controls allow the user to configure parameters, settings, and listening modes.

# 2. Intended Use

The Soundwave Hearing Sontro® Self-Fitting OTC Hearing Aids are intended to amplify sounds for use by individuals 18 years and older with perceived mild to moderate hearing impairment. The device is intended for over-the-counter sale and use without the assistance of a hearing care professional.

## 3. Indications for Use

The Soundwave Hearing Sontro® Self-Fitting OTC 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. The device is intended for use without the assistance of a hearing care professional.

## 4. Device Information

Per 21 CFR 874.3325, a self-fitting wireless air-conduction hearing aid is a wearable soundamplifying device intended to compensate for impaired hearing. It incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy, enabling users to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air-conduction hearing aids are Class II medical devices. The Self-Fitting hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver that can be coupled with domes. Self-fitting hearing aids are controlled via button controls and wirelessly via the smart hearing app (iOS and Android). The controls allow users to adjust the volume setting and customize the hearing mode program.

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# 5. Self-Selection Labeling

Self-selection labeling has been included in the Sontro Self-Fitting OTC Hearing Aid's IFU to mitigate the risk of improper self-selection. Summarized, it addresses:

- A warning against the use of people younger than 18 years of age. .
- Identifying criteria that indicate the user should see a hearing professional. ●
- Identifying situations where Sontro Self-Fitting OTC Hearing Aids may help you hear better.
- Identifying situations in which Sontro Self-Fitting OTC Hearing Aids may not be suitable ● for the user.
- Informing the user that the Sontro Self-Fitting OTC Hearing Aids will not restore normal hearing.
- Informing the user that it is good health practice to have hearing loss evaluated by an ● appropriate healthcare professional.

## 6. Special Controls

The Sontro Self-Fitting OTC Hearing Aids conform to the special controls stated in 21 CFR 874.3325. Soundwave has satisfied these requirements through:

- . Clinical Data
- Non-Clinical Performance Testing ●
- Human Factors Validation ●
- Labeling .

# 7. Comparison of Technological Characteristics

The subject (Sontro Self-Fitting OTC Hearing Aid) and the predicate (Bose SoundControl Hearing Aid) are self-fit hearing aids. The predicate device is considered direct-to-consumer since it was cleared before the finalization of the OTC Hearing Aid Rule; the subject device is an over-the-counter hearing aid. Both the predicate and subject devices are indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both the predicate and subject hearing aids to allow the user to control and customize the device to the user's hearing needs.

Both devices contain the same technological characteristics:

- Self-Fit Hearing Aid ●
- Bluetooth
- On Device Controls ●

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- A traditional receiver-in-the-canal (RIC) style form factor ●
- Replaceable 312 Battery .
- Software App .
- Software Platform Compatibility (iOS, Android) .

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### Substantial Equivalence Technological Comparison Summary:

Table 1 Soundwave Hearing conducted a comprehensy technological comparison between the Sontro® Self-Fiting OTC Hearing Aids and the predicate device (K211008) to facilitate substantial equivalence.

| Topic | Subject Device (Sontro®<br>Self- Fitting OTC Hearing<br>Aid) | Predicate Device<br>(Bose SoundControl<br>Hearing Aid) | Discussion of Similarities and Differences |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fitting | Self-Fit<br>Apply personalized gain<br>settings based on user<br>in-situ test.<br>Utilizes the validated NAL-<br>NL2 fitting algorithm. | Self-Fit<br>Loudness and Fine-Tuning.<br>Utilizes a proprietary fitting<br>algorithm. | Similarities: Both the predicate and subject devices use<br>proprietary software to program the user's hearing needs<br>to the devices. This self-fitting is done after assessing<br>the user's hearing loss has been assessed by the software<br><br>Differences: The subject has three patents for self-<br>fitting, which are used in the software applying<br>personalized gain settings based on a user in-situ test<br>and utilizing the validated NAL-NL2 fitting<br>algorithm, personalizing the hearing threshold to the<br>user's unique requirements for hearing amplification.<br>There are no pre-suite hearing thresholds for the<br>software to choose from. The Predicate utilizes a<br>proprietary fitting algorithm, fitting one of several<br>programs that best match the user's hearing threshold<br>with loudness and fine-tuning by the user.<br>NAL-NL2 is widely used by hearing professionals.<br>Clinical and non-clinical testing supports the subject<br>device's equivalence to the predicate despite<br>technological differences. Clinical and non-clinical<br>testing performed are detailed in this summary. |

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| Intended user<br>Population | 18+ Years Old | 18+ Years Old | The same: The subject and predicate are intended<br>for an 18+ population. This is the intended<br>population requirement in the OTC hearing Aid<br>Rule. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Soundwave Hearing<br>Sontro® Self-Fitting OTC<br>Hearing Aids are intended<br>to amplify sound for<br>individuals 18 years of age<br>or older with perceived<br>mild to moderate hearing<br>impairment. They are<br>adjusted by the user to<br>meet the user's hearing<br>needs. The device is<br>intended for use without<br>the assistance of a hearing<br>care professional. | The Bose SoundControl<br>Hearing Aids are<br>intended to amplify<br>sound for adults 18 years<br>of age or older with<br>perceived mild to<br>moderate hearing<br>impairment. It is adjusted<br>by the user to meet the<br>user's hearing needs. No<br>preprogramming or<br>hearing test is necessary.<br>The device is intended<br>for direct-to-consumer<br>sales without the<br>assistance of a hearing<br>care professional. | Similar: The subject Indications for Use is similar to the<br>predicate, with the appropriate adjustments in accordance<br>with the OTC Hearing Aid Final Rule. |

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| Technology | Wireless, self-fitting air-<br>conduction hearing aid | Wireless, self-fitting<br>air-conduction hearing<br>aid | The same: The technology between the subject and<br>predicate is the same. The predicate and subject use<br>(RIC) Receiver in the canal technology. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing | Behind the ear hearing aid<br>housing. Speakers<br>(receiver) and domes that<br>insert into each ear separate<br>left and right ear devices<br>with user-control push<br>buttons on each unit.<br><br>Image: Hearing aid diagram with labels for receiver, volume button, open ear dome, microphone, and battery door. | Behind the ear hearing aid<br>housing. Speakers<br>(receiver) and domes that<br>insert into each ear separate<br>left and right ear devices<br>with user-control push<br>buttons on each unit.<br><br>Image: Hearing aid diagram with labels for eartip, speaker, cable, battery door, world volume up button, microphones, hearing aid body, and world volume down button. | Similarities: The subject and predicate design are<br>similar; they are BTE with receivers and domes that<br>insert into each ear with separate left and right ear<br>devices with user control push buttons on each unit.<br><br>Differences: The shapes of the subject and predicate<br>device housings are slightly different in design.<br><br>The design differences were tested with a Usability<br>study. Participants were asked questions relating to<br>the physical appearance and comfort of the subject<br>device, with a passing result once responses were<br>evaluated. |

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| Dimensions | Overall, without cable:<br>27.2 mm long (height)<br>13.2 mm wide (depth) X<br>7.8 mm thick (width) | Overall, with cable:<br>33 mm long x 23 mm wide<br>x 18 mm thick | Similarities: The subject and the predicate design are<br>similar; they are both BTE with receivers and domes<br>that insert into each ear with separate left and right ear<br>devices with user control push buttons on each unit.<br><br>Differences: The shapes of the subject and predicate<br>device housings are slightly different in design.<br><br>The design differences were tested with a Usability<br>study. Participants were asked questions relating to<br>the physical appearance and comfort of the subject<br>device, with a passing result once responses were<br>evaluated. |
|-----------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Expected<br>Service<br>Life | 2 years | 2 years | The same: The expected service life between the<br>subject and predicate is the same. |

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| On<br>Device<br>Controls | Yes | Yes | Similarities: The subject and the predicate design are<br>similar, with user-control push buttons on each unit.<br><br>Differences: The subject's shape and predicate device<br>controls differ slightly in design.<br><br>The design differences were tested with a Usability<br>study. Participants were asked questions relating to<br>the modes and settings of the subject device, with a<br>passing result once responses were evaluated. |
|--------------------------|-----|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------|-----|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Bluetooth | 2.4 GHz | 2.4 GHz | The Same: The Bluetooth connection between the<br>subject and predicate is the same. |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wireless<br>communication | Wireless<br>communication<br>with<br>handheld<br>device<br>via<br>Bluetooth | Wireless<br>communication<br>with<br>handheld<br>device<br>via<br>Bluetooth | The Same: The wireless communication between the<br>device and the handheld device (software) is the same<br>between the subject and predicate. |
| Wireless<br>coexistence | The Sontro® OTC Hearing<br>Aid uses standard 2.4GHz<br>Classic Bluetooth and<br>Bluetooth Low Energy<br>(BLE) standards to<br>communicate between the<br>hearing aid and the user's<br>Bluetooth-enabled device.<br>From the risk assessment,<br>the temporary loss of<br>Bluetooth communication<br>from interfering RF signals<br>is appropriately considered a<br>negligible risk, and<br>according to AAMI TIR 69,<br>wireless coexistence testing<br>is not required. Note that the | The Bose BMD-0012<br>Hearing Aid uses standard<br>2.4GHz Classic Bluetooth<br>and Bluetooth Low Energy<br>(BLE) standards to<br>communicate between the<br>hearing aid and the user's<br>Bluetooth-enabled device.<br>From the risk assessment,<br>the temporary loss of<br>Bluetooth communication<br>from interfering RF signals<br>is appropriately considered<br>a negligible risk, and<br>according to AAMI TIR 69,<br>wireless coexistence testing | The Same: The wireless coexistence between the<br>device and the handheld device (software) is the same<br>between the subject and predicate. Both use 2.4GHz<br>classic Bluetooth Low Energy (BLE) standards to<br>communicate between the hearing aid and the user's<br>Bluetooth-enabled device. |
| | is not required. Note that | | |
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| | interruption of device<br>control from the App<br>would be similar to when<br>the user is separated from<br>their Bluetooth-enabled<br>device. | interruption of device<br>control from the App<br>would be similar to when<br>the user is separated from<br>their Bluetooth-enabled<br>device. | |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wireless user<br>control<br>functions via<br>mobile app | Volume Control Modes<br>Quiet - Omnidirectional<br>mic Noise - Adaptive mic<br>Entertainment - Fixed<br>Forward mic<br>Left/Right independent<br>control. | Volume Control Modes<br>Focused, Conversation,<br>Outdoors, Music, Television<br>Mic Control<br>Everywhere, Front<br>Left/Right Balance | Similarities: Both the subject and predicate software<br>have the ability for the user to control: Volume,<br>modes, and two microphones. The subject and the<br>predicate devices allow for omnidirectional and<br>speech-focus speech options. Omnidirectional and<br>speech-focused options, both devices work within the<br>same 120-degree focus.<br>Differences: Subject device modes, microphones, and<br>left/right balance differ in technological function and<br>naming. |

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| The Sontro® OTC<br>Hearing Aids use two<br>microphones on the<br>device, which allow for<br>directionality. This<br>directionality operates<br>specifically in the three<br>modes of operation. | The Bose Predicate device<br>has two microphones on the<br>device, which, during use,<br>may be configured by the<br>user to be Everywhere (360<br>degrees) or in Front (fixed<br>120 degrees forward)<br>direction of operation. | The additional functionality of the left/right balance of<br>the predicate device does not raise questions of safety or<br>effectiveness for the device.<br>The added Adaptive directionality of the subject device<br>does not raise questions about the safety or effectiveness<br>of the device.<br>Clinical and non-clinical data from a usability study<br>and data from a clinical validation study support |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When the device is in<br>Quiet Mode, the<br>microphones work omni-<br>directional or 360<br>degrees. While in<br>Entertainment Mode, the | | substantial equivalence. Additionally, a usability study<br>was performed where participants were asked<br>questions regarding the mode and settings, with a<br>passing result once the results were evaluated. |

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| | Microphones work in a<br>fixed forward direction<br>with a spread of 120<br>degrees. While in Noise<br>Mode, the microphones<br>work in a forward cone of<br>120 degrees, but the focus<br>is towards the loudest<br>human speech, called<br>Adaptive Directionality. | | |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Demonstrate<br>that the hearing<br>Aid device<br>initiates<br>Bluetooth<br>pairing and<br>Bluetooth<br>control<br>functionality | Pairing and control with the<br>paired mobile device. | Pairing and control with the<br>paired mobile device. | The Same: Both the subject and predicate devices use<br>Bluetooth capabilities to pair the devices with the<br>software on the handheld device. |
| Battery | Hearing Aid with a single<br>replaceable 312 zinc-air<br>cell 1.5V, 4 day, 14hr/day<br>battery coin cell | Hearing Aid with a single<br>replaceable 312 zinc-air<br>cell 1.5V, 4 day, 14hr/day<br>battery coin cell | The Same: Both the subject and the predicate use a<br>single replaceable 312 zinc-air 1.5V, 4day, 14hr/day<br>battery, coin cell |
| Battery Life | Up to four days<br>assuming 14hr day<br>usage, depending on the<br>brand and age of<br>batteries | Up to four days<br>assuming 14hr day<br>usage, depending on the<br>brand and age of<br>batteries | The Same: Both the subject and the predicate use a<br>single replaceable 312 zinc-air 1.5V, 4day, 14hr/day<br>battery, coin cell |

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| Microphones | During use, the earbuds'<br>microphone may be<br>configured by the user in<br>the following modes: Quiet<br>mode (Omnidirectional<br>360- degrees degree),<br>Entertainment mode (Fixed<br>Directionality 120-degree<br>Speech focused), or Noise<br>Mode (Adaptive<br>Directionality 120-degree) | During use, the earbuds'<br>microphone may be<br>configured by the user in<br>the following modes:<br>Everywhere mode<br>(Omnidirectional 360-<br>degree) or Front mode<br>(Fixed Directionality 120-<br>degree Speech focused). | Similarities: The subject and predicate devices allow<br>omnidirectional 360-degree and speech-focus 120-<br>degree options.<br><br>Differences: The subject device supports an additional<br>adaptive directional 120-degree noise mode that allows<br>the earbuds to determine the most suitable directionality<br>for the microphones for the given environment,<br>dynamically changing the directional pattern to reduce<br>the loudest sounds from the rear.<br><br>The added automatic selection of directionality does notNonclinical data from a usability study and data from a<br>clinical validation study support substantial equivalence. |
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| Device Control | On-Device user controls:<br>- Volume up/down<br>- Mode change<br>- Bluetooth Pairing<br>- Clearing out hearing<br>aid setting | On-Device user controls:<br>- Volume up/down<br>- Mode change<br>- Bluetooth Pairing<br>- Clearing out hearing<br>aid setting | The Same: Both the subject and the predicate use on-<br>device user controls of a rocker switch that allows for<br>the following: volume up/down, mode change,<br>Bluetooth pairing, and clearing out the hearing aid<br>setting. |
| Compression | 16-channel wideband<br>dynamic range compression | 12-channel wideband<br>dynamic range compression | Similarities: The subject and the predicate use<br>wideband dynamic range compression |
| | | | Differences: The subject uses 16 channels, and the<br>predicate uses 12 channels |
| | | | The 4 additional channels on the subject device are<br>added into the base, mid, and treble and offer similar<br>spectral tilt as the predicate device. The channels are<br>equal divisions of the frequency spectrum from 200 Hz<br>to 8000 Hz. Both the predicate and Sontro® Self-Fitting<br>OTC Hearing Aids share the same spectrum. However,<br>the predicate divides this spectrum into 12 sections<br>(channels) of 650 Hz each, and the subject devicedivides the spectrum into 16 sections (channels) or 488<br>Hz. Each channel can be amplified to meet the needs of<br>the user with hearing loss within a channel. The 4<br>additional channels do not raise different questions of<br>safety or effectiveness. |
| Noise<br>Reduction | Active noise reduction.<br>Impact noise control. | Active noise<br>reduction. Impact<br>noise control. | <b>The Same:</b> The subject and the predicate use active<br>noise reduction with impact noise control. |
| Feedback<br>Cancellation | Feedback canceller. | Feedback canceller. | <b>The Same:</b> The subject and the predicate use a<br>feedback canceller. |
| Mobile app | Compatible with iOS and<br>Android. | Compatible with iOS and<br>Android. | The Same: The subject and the predicate are compatible<br>with iOS and Android. |
| Telephony…