MDHearingAid app, MDHearingAid Smart hearing aids

K220303 · Mdhearingaid · QDD · Aug 4, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K220303
• Device Name: MDHearingAid app, MDHearingAid Smart hearing aids
• Applicant: Mdhearingaid
• Product Code: QDD · Ear, Nose, Throat
• Decision Date: Aug 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3325
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, 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.

Device Story

Wireless BTE air-conduction hearing aid system; utilizes Intricon Lumen 200B platform. Inputs: ambient sound via microphones. Processing: 8-channel wide band dynamic range compression; adaptive feedback cancellation; 12-channel layered noise reduction; NAL-NL2 fitting algorithm. Outputs: amplified sound via thin tubing/earpiece. Operated by patient via MDHearing mobile app (iOS/Android) or on-device push buttons. App allows personalization, volume control, program selection, and advanced settings (noise reduction, directionality, equalizer). Powered by size 312 zinc-air battery. Used in home/daily environments. Benefits: improved speech intelligibility and hearing for mild-to-moderate impairment without professional intervention.

Clinical Evidence

Randomized clinical validation study (N=64) compared self-fit vs. professional-fit. Primary endpoints: APHAB and SSQ12 benefit scores. Secondary: QuickSIN speech-in-noise recognition. Results: Self-fit group showed non-inferiority to professional-fit group in subjective and objective benefit measures. Real-ear measures (REMs) confirmed reliability of self-fitting method (MAD < 2 dB) and validity of amplification targets. No adverse events reported.

Technological Characteristics

BTE form factor; Intricon Lumen 200B platform. Power: 1.3Vdc size 312 zinc-air battery. Connectivity: Bluetooth Low Energy (2.4 GHz). Signal processing: 8-channel wide band dynamic range compression, adaptive feedback cancellation, 12-channel layered noise reduction. Standards: ANSI S3.22:2014, ANSI CTA 2051:2017, IEC 60601-1, IEC 60601-1-2, ISO 10993 (biocompatibility).

Indications for Use

Indicated for individuals 18+ with perceived mild to moderate hearing impairment. No contraindications specified.

Regulatory Classification

Identification

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

Special Controls

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

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

Predicate Devices

• Bose Hearing Aid (DEN180026)

Submission Summary (Full Text)

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August 4, 2022

MDHearingAid Doug Breaker CEO 150 N Michigan Avenue Suite 400 Chicago, Illinois 60601

Re: K220303

Trade/Device Name: MDHearing Smart Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: ODD Dated: July 1, 2022 Received: July 5, 2022

Dear Doug Breaker:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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

Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K220303

Device Name MDHearing Smart Hearing Aid

#### Indications for Use (Describe)

The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are to meet the user's hearing needs. No Pre-programming or hearing test is necessary. The device is intended for direct-toconsumer sale and use without the assistance of a hearing care professional.

Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421)

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary - K220303

#### . SUBMITTER

MDHearingAid 150 N. Michigan Avenue Suite 400 Chicago, IL 60601

Contact Person: Doug Breaker Phone: [phone] Fax: [phone]

Date Prepared: June 29, 2022

#### SUBJECT DEVICE

Trade / Device Name: MDHearing Smart Hearing Aid Common or Usual Name: Self-fitting air-conduction hearing aid Classification Name: Self-fitting air-conduction hearing aid Regulation Number: 21 CFR 874.3325 Product Code: QDD Requlatory Class: Class II Panel: Ear, Nose, and Throat Devices

#### PREDICATE DEVICE

Bose® Hearing Aid (DEN180026)

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The MDHearing Smart Hearing Aid is a self-fitting wireless air conduction hearing aid system consisting of the Intricon Lumen 200B hardware and the MDHearing mobile application, which is an "app" compatible only with MDHearing devices of a Smart Hearing Aid product line, designed to interface with a user's compatible smartphone or tablet to personalize and manipulate the device and its settings. The wireless hearing aid (Figure 1) incorporates microphones and a receiver encased in the behind-the-ear (BTE) hearing aid body, delivering amplified sound to the ear via standard thin tubing coupled to an earpiece for audio input into the ear. The hearing aid can be controlled wirelessly via Bluetooth Low Energy® using the MDHearing app or manually with on-device push buttons for changing volume and programs. The controls accessible through the MDHearing app and on the hearing aids are used to

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Image /page/4/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized letter "M" in blue, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a curved line that resembles a sound wave, suggesting a connection to hearing or sound technology.

configure parameters, settings, and listening modes of the devices. The MDHearing Smart Hearing Aid is powered by a standard disposable size 312 zinc-air hearing aid battery.

Image /page/4/Figure/3 description: This image is a diagram of a CORE hearing aid. The diagram labels the different parts of the hearing aid, including the microphones, volume/program button, stabilizer bar, battery compartment, tubing base, thin tubing, and ComfortTIP. The diagram also shows a close-up of the CORE body and snap end.

Figure 1. Diagram of the MDHearingAid® CORE, a wireless hearing aid of the MDHearing Smart product line, compatible with the MDHearing app and utilizing the Intricon Lumen 200B platform, representative of the subject device.

The MDHearing mobile application (MDHearing app) is designed to function with a user's compatible personal device, providing an interface for remote, wireless control and configuration of MDHearing Smart Hearing Aids. The app is available free for download on iOS or Android based systems. The MDHearing app is compatible only with MDHearing devices of the Smart Hearing Aid product line. It cannot be used to pair a device with any other brand of hearing aid or with hearing aids that are not part of the Smart product line. The MDHearing app cannot be used independently of MDHearing Smart Hearing Aids.

The MDHearing app allows the user to program the MDHearing Smart Hearing Aid through "self-fitting" strategies by changing various basic functions such as programs and volume, as well as more advanced settings including noise reduction, microphone directionality, and bass, treble, and mid frequency (or Equalizer) settings. Some of these Advanced Settings can only be adjusted after the user completes a personalization process, resulting in a personal profile, or an approximation of hearing sensitivity upon which the hearing aids are fit using the NAL-NL2 fitting formula. The validated NAL-NL2 fitting formula aims to maximize speech intelligibility while maintaining comfortable overall loudness, and it is widely used by hearing care professionals to fit individuals with mild to moderate hearing loss.

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# MDHearing

#### V. INTENDED USE / INDICATIONS FOR USE

The MDHearing Smart Hearing Aids are self-fitting air-conduction hearing aids, 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.

#### VI. LABELING

Self-Selection Labeling has been included in the MDHearing Smart Hearing Aid User Manual to mitigate the risk of improper self-selection. Summarized, it addresses the following:

- Identifying situations in which the MDHearing Smart Hearing Aid may help users hear ● better.
- . Identifying situations in which the MDHearing Smart Hearing Aid may not be right for users.
- Identifying criteria that indicate users should see a hearing professional. ●
- Informing users that the MDHearing Smart Hearing Aid will not restore normal hearing. ●
- Informing users that it is good health practice to have hearing loss evaluated by a licensed healthcare professional.

#### VII. SPECIAL CONTROLS

The MDHearing Smart Hearing Aid conforms to the special controls stated in 21 CFR 874.3325. These requirements were satisfied through the following:

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

#### VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject (MDHearing Smart Hearing Aid) and the predicate (Bose® Hearing Aid -DEN180026) devices are self-fit, direct-to-consumer hearing aids indicated for individuals 18 and older with perceived mild to moderate hearing impairment. The same fundamental technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs.

The key similarities and differences between the predicate device and the subject device with respect to the technological characteristics are summarized in the table below. Any differences in technological characteristics between the subject and predicate device have been addressed

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Image /page/6/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized blue wave-like graphic to the left of the text "MDHearing". The text is in a bold, dark blue font.

through testing to a known performance standard or by showing equivalency in terms of function. Therefore, these differences are not significant and do not raise additional questions of safety or effectiveness for the subject device.

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Image /page/7/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized letter "M" in light blue, followed by the text "MDHearing" in a darker blue font. The "M" is designed with curved lines, giving it a modern and sleek appearance.

Key Similarities and Differences between the Bose® Hearing Aid (Predicate Device) and the MDHearing Aid (Subject Device)

| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Bose Hearing Aid is<br>intended to amplify sound for<br>individuals 18 years of age or<br>older with perceived mild to<br>moderate hearing impairment. It<br>is adjusted by the user to meet<br>the user's hearing needs. No<br>pre-programming or hearing test<br>is necessary. The device is<br>intended for direct-to-consumer<br>sale and use without the<br>assistance of a hearing care<br>professional. | The MDHearing Smart<br>Hearing Aids are self-fitting<br>air-conduction hearing aids,<br>intended to amplify sound for<br>individuals 18 years of age<br>or older with perceived mild<br>to moderate hearing<br>impairment. They are<br>adjusted by the user to meet<br>the user's hearing needs. No<br>pre-programming or hearing<br>test is necessary. The device<br>is intended for<br>direct-to-consumer sale and<br>use without the assistance of<br>a hearing care professional. | The Indications for Use and<br>intended users are the same. |
| Technology | Wireless, self-fitting<br>air-conduction hearing aid | Wireless, self-fitting<br>air-conduction hearing aid | Same |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| Housing | Hearing aid neckband housing<br>that connects to both the left and<br>right ear units with user controls<br>on right earbud wire<br>Image: Bose Hearing Aid | Traditional behind-the-ear<br>(BTE) form factor<br>Image: MDHearing Smart Hearing Aid | Although the subject device<br>hearing aid housing is<br>wireless and BTE instead of<br>a neckband with wired<br>earbuds, the difference in<br>housing does not raise<br>different questions of safety<br>or effectiveness.<br>Non-clinical and clinical<br>performance testing and<br>validation data, including<br>usability and safety testing,<br>support substantial<br>equivalence. |
| Wireless communication | Wireless communication with<br>handheld device via Bluetooth | Wireless communication with<br>handheld device via<br>Bluetooth | Same |
| Wireless control functions via<br>mobile application | -Volume control<br>-Modes (everywhere, front,<br>focused)<br>-Tone correction<br>-Left/Right balance | -Volume control (can adjust<br>overall or R/L individually)<br>-Programs ("Automatic",<br>"Quiet", "Conversation",<br>"Restaurant")<br>-Equalizer for Low-, Mid-,<br>and High-tones<br>-Noise reduction<br>-Directionality | The additional wireless<br>control functions supported<br>for the subject device do not<br>raise different questions of<br>safety or effectiveness.<br>Non-clinical and clinical<br>performance testing and<br>validation data, including<br>usability and safety testing,<br>support substantial<br>equivalence. |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| Device control | On-Device user controls:<br>- Volume up/down microphone<br>- Volume up/down streaming<br>- Power on/off button<br>- Bluetooth pairing button | On-Device user controls:<br>-Volume up/down<br>-Program up/down<br>-Power on/off (via hearing<br>aid battery door closed or<br>open) | Sound adjustment controls<br>are similar. Powering off/on<br>and Bluetooth pairing mode<br>for the subject device are<br>controlled by opening/closing<br>battery door. The subject<br>device does not support<br>streaming, so the absence of<br>those controls, and the<br>different means of engaging<br>Bluetooth and turning the<br>device on/off, do not raise<br>different questions of safety<br>or effectiveness.<br>Non-clinical and clinical<br>performance testing and<br>validation data, including<br>usability and safety testing,<br>support substantial<br>equivalence. |
| Mobile App | Mobile application, on handheld<br>device (iOS or Android) used to<br>configure parameters, settings,<br>and listening modes | Mobile application, on<br>handheld device (iOS or<br>Android) used to configure<br>parameters, settings, and<br>listening modes | Same |
| Battery | Single cell rechargeable<br>3.7V/270mAh li-ion battery inside<br>neckband | Replaceable, disposable,<br>1.3Vdc zinc-air hearing aid<br>battery (size 312) | Other legally marketed<br>hearing aids (including those<br>exempt from 510(k) fitted by<br>hearing care professionals) |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| | | | also utilize disposable<br>zinc-air size 312 hearing aidbatteries. As such, the<br>difference in power source<br>does not raise different<br>questions of safety or<br>effectiveness.<br><br>Non-clinical and clinical<br>performance testing and<br>validation data, including<br>usability and safety testing,<br>support substantial<br>equivalence. |
| Microphones | Microphones in earbud may,<br>during use, be configured by the<br>user in omnidirectional or<br>directional modes. | Microphones on hearing aid<br>body may, during use, be<br>configured by the user in<br>omnidirectional or directional<br>modes. | Both the subject device and<br>the predicate device allow for<br>omnidirectional and speech<br>focus options.<br><br>The subject device supports<br>an adaptive directional mode<br>that allows the hearing aids<br>to determine the most<br>suitable directionality for the<br>microphones for the given<br>environment.<br><br>The added automatic<br>selection of directionality<br>does not raise different<br>questions of safety or |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| | | | effectiveness. |
| Compression | 12 channel wide band dynamic<br>range compression | 8 channel wide band<br>dynamic range compression | The difference in the number<br>of channels is<br>inconsequential for achieving<br>adequate spectral tilt, with<br>both subject and predicate<br>devices having 12 gain<br>adjustment bands, and this<br> |
| Noise reduction | Active noise reduction, steady<br>state noise reduction, impulse<br>noise control | 12-channel layered noise<br>reduction | While differences in the<br>implementation of noise<br>reduction exist, these do not<br>raise different questions of<br>safety or effectiveness.<br>Non-clinical and clinical<br>performance testing and<br>validation data support<br>substantial equivalence. |
| Feedback cancellation | Feedback canceller | Adaptive feedback<br>cancellation | Same |
| Self-fitting method | Loudness and Fine-Tuning. | Apply personalized gain | Instead of a proprietary |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| | Utilizes a proprietary fitting<br>algorithm. | settings based on user input<br>and fine-tuning. Utilizes<br>NAL-NL2 fitting algorithm. | algorithm as used by the<br>predicate device, subject<br>device uses the validated<br>NAL-NL2 fitting algorithm,<br>widely used by hearing care<br>professionals to fit persons<br>with mild to moderate<br>hearing loss.<br>Legally marketed hearing<br>aids exempt from 510(k) also<br>embed the NAL-NL2 fitting<br>algorithm, but these exempt<br>hearing aids are fitted by<br>hearing care professionals.<br>As such the difference in<br>fitting strategy does not raise<br>different questions of safety<br>or effectiveness.<br>Data from a clinical<br>validation study support<br>substantial equivalence. |
| Remote firmware update | Unknown | Remote firmware update via<br>cloud-based solutions with<br>the MDHearing app | Remote firmware update<br>allows MDHearing to<br>maintain and improve Smart<br>hearing aids and strengthen<br>cybersecurity as new mobile<br>operating systems are<br>released. This is assessed<br>as part of the cybersecurity |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| | | | risk assessment, and this<br>feature does not raise<br>different questions of safety<br>or effectiveness. |
| Wireless coexistence | The Bose BMD-001 Hearing Aid<br>uses standard 2.4GHz Classic<br>Bluetooth and Bluetooth Low<br>Energy (BLE) standards to<br>communicate between the<br>hearing aid and the user's<br>Bluetooth enabled device. From<br>the risk assessment, the<br>temporary loss of Bluetooth<br>communication from interfering<br>RF signals is appropriately<br>considered a negligible risk and<br>according to AAMI TIR 69,<br>wireless coexistence testing is<br>not required. | The MDHearing Smart<br>(Intricon Lumen200B)<br>Hearing Aid uses the same<br>standard 2.4GHz Classic<br>Bluetooth and Bluetooth Low<br>Energy (BLE) standards as<br>the predicate to<br>communicate between the<br>hearing aid and the user's<br>Bluetooth enabled device.<br>Wireless coexistence testing<br>is not required per AAMI TIR<br>69. | Same |
| Electroacoustic parameters<br>(special control 2) | Maximum output limits, distortion<br>levels, self-generated noise<br>levels, latency, full on gain,<br>frequency response, and other<br>parameters as required per 21<br>CFR 874.3325(b)(2)<br>demonstrated to perform to<br>specifications of ANSI<br>S3.22:2014 and ANSI CTA<br>2051:2017 standards. | Maximum output limits,<br>distortion levels,<br>self-generated noise levels,<br>latency, full on gain,<br>frequency response, and<br>other parameters as required<br>per 21 CFR 874.3325(b)(2)<br>demonstrated to perform to<br>specifications of ANSI<br>S3.22:2014 and ANSI CTA<br>2051:2017 standards. | Same<br>See Non-Clinical<br>Performance Testing<br>summary ANSI comparison<br>table. |
| Characteristic | Predicate Device: Bose<br>Hearing Aid (DEN180026) | Subject Device:<br>MDHearing Smart Hearing<br>Aid | Discussion |
| Exposure to nonionizing<br>radiation (special control 5i) | The Bose Hearing Aid contains a<br>Bluetooth radio transmitter<br>operating in the ISM band (2.400<br>to 2.4835 GHz) at less than 10<br>mW EIRP. The output power<br>level at these operating<br>frequencies of the Bose Hearing<br>Aid was deemed sufficiently safe<br>in terms of human exposure to<br>nonionizing radiation for the<br>intended use. | The equipment operates in<br>the ISM 2.4 GHz band (2.40<br>- 2.4835 GHz), using the<br>Bluetooth® SMART protocol,<br>and the maximum RF Power<br>transmitted in that band is<br>-10.1 dBm EIRP | Same |

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Image /page/8/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized letter "M" on the left, followed by the text "MDHearing" on the right. The letter "M" is designed with a flowing, wave-like appearance, and the text is in a bold, sans-serif font.

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Image /page/9/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized blue wave-like symbol on the left, followed by the text "MDHearing" in a dark blue, bold font. The wave-like symbol appears to be a stylized representation of sound waves, which is relevant to the company's focus on hearing solutions.

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Image /page/10/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized letter "M" in light blue, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a curved, wave-like shape, giving it a modern and dynamic appearance.

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Image /page/11/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized letter "M" in light blue, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a curved, wave-like shape, giving it a modern and dynamic appearance.

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Image /page/12/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized letter "M" in light blue, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a curved, wave-like shape, giving it a modern and dynamic appearance.

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Image /page/13/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized letter "M" in blue, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a flowing, wave-like shape, giving it a modern and dynamic appearance.

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Image /page/14/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized blue letter "M" that resembles a sound wave, followed by the text "MDHearing" in a bold, dark blue font. The logo is simple and modern, and it is likely used to represent a company that specializes in hearing aids or other hearing-related products.

While the proposed predicate and subject device are not identical, the technological characteristics are similar, and the technological differences between the predicate device and the subject device do not raise different questions of safety and effectiveness. The table above identifies each of the key technological differences between the MDHearing Aid and the predicate device as well as the testing performed for each of these differences to demonstrate substantial equivalence. The non-clinical (including usability) and clinical performance testing demonstrate substantially equivalent safety and effectiveness of the MDHearing Smart Hearing Aid as compared to the predicate device.

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#### IX. CLINICAL PERFORMANCE TESTING

# Study Design

The clinical study of the MDHearing Smart Hearing Aids and app was a single site, randomized clinical validation study comparing fitting outcomes between individuals using the hearing aids as self-fit versus those fit with the same device by a professional according to audiologic standards of care in a clinical setting. Participants were randomized 1:1 into the two fitting strategies and completed a 1-month field trial in either the "Professional-Fit" group or a "Self-Fit" group. Various performance factors and hearing aid outcomes are examined, including subjective and objective hearing aid benefit with the self-fit MDHearing Smart Hearing Aid versus professional-fit of the same device, appropriateness of amplification as assessed via probe-microphone (real ear) verification measures, and safety data. Reliability of the functionality of the MDHearing app for self-fitting and fine-tuning of the hearing aids was also evaluated.

# Subject Demographics

Sixty-four adults aged 18 years or older with sensorineural hearing from mild to moderate degree completed this study. Table 1a below provides information on the total study population, and Table 1b provides information on subject demographics by group ("Self-Fit" / "Professional-Fit") of the study.

| Characteristic | N / Total (%) |
|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Age<br>18 to 39 years of age<br>40 to 49 years of age<br>50 to 59 years of age<br>60 to 69 years of age<br>60 to 79 years of age | 5 / 64 (8%)<br>8 / 64 (13%)<br>13 / 64 (19%)<br>22 / 64 (35%)<br>16 / 64 (25%) |
| Sex<br>Female<br>Male | 36 / 64 (57%)<br>28 / 64 (43%) |
| Hearing Loss Degree<br>Mild<br>Mild to Moderate | 15 / 64 (24%)<br>49 / 64 (76%) |
| Hearing Aid Use<br>Experienced<br>New | 40 / 64 (63%)<br>24 / 64 (27%) |

### Table 1a. Study Population Summary

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Image /page/16/Picture/0 description: The image shows the logo for MDHearing. The logo consists of a stylized blue "M" shape on the left, followed by the text "MDHearing" in a sans-serif font. The color of the text is also blue, matching the "M" shape. The logo is simple and modern, with a focus on the company name.

| Characteristic | N / Total (%) |
|------------------------------------------------|---------------|
| Technology Use Level* (as reported by subject) | |
| Low (1-4) | 6 / 64 (9%) |
| Mid (5-7) | 24 / 64 (38%) |
| High (8-10) | 34 / 64 (53%) |

*Participants were asked to self-rank from 1 to 10 (1: not comfortable at all; 10: very comfortable) their comfort level with technology of electronic devices (e.g., smartphones).

| Demographic Category | All Subjects | |
|-----------------------------------------------|--------------|------------------|
| | Self-Fit | Professional-Fit |
| Sample Size | 32 | 32 |
| 4 Frequency PTA* (dB HL) (mean, s.d.) | 29.8, 14.2 | 35.2, 14.8 |
| Mild Hearing Loss (# of subjects) | 9 | 6 |
| Mild to Moderate Hearing Loss (# of subjects) | 23 | 26 |
| Experienced Hearing Aid Users (# of subjects) | 19 | 21 |
| New Hearing Aid Users (# of subjects) | 13 | 11 |
| Tech. Level (mean, s.d.) | 7.8, 1.8 | 6.8, 2.7 |
| Age (Years) (mean, min-max) | 58, 31-76 | 62, 31-79 |
| Sex (Female, Male) | 17, 15 | 19, 13 |

## Table 1b. Subject Demographics by Group

* Thresholds measured at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz

## Study Procedures

At the first study visit, prior to randomization to groups, all participants completed an assessment of self-fitting reliability to evaluate the performance consistency (or reliability) and validity of the self-fitting and user-controlled adjustments made to hearing aid settings via the MDHearing app. Having completed the personalization process using the MDHearing app and wearing the hearing aids, participants then listened to a recorded speech passage at their most comfortable loudness level (MCL) and were asked to adjust their hearing aids for listening comfort. Probe-microphone (real ear) measures of hearing aid output were completed after each of three iterations of this procedure to evaluate successive gain measurements for stability, and to compare average user-selected gain in the procedure to professionally selected target levels.

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# MDHearing

After the laboratory reliability measures were completed, all participants were issued a new pair of MDHearing Smart Hearing Aids and underwent initial fitting of the devices either by a clinician programming (professional-fit) or by completing the personalization process using the MDHearing app (self-fit). The baseline visits also included, for all participants, unaided speech-in-noise recognition testing (soundfield Quick Speech in Noise [QuickSIN] test) and completion of pre-fitting (unaided) sections of the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the 12-item short form of the Speech, Spatial and Qualities of Hearing scale (SSQ12).

After one month of field use, participants completed outcome assessments including aided sections of the APHAB, post-fitting "Benefit" version of the SSQ12, and aided QuickSIN testing; a user satisfaction questionnaire was administered for the self-fit group only at the final visit. The professional group had an interim visit for hearing aid reprogramming and fine tuning, if needed, as well as routine hearing aid counseling 2 weeks after baseline intake. Self-fit participants did not have an interim visit with a professional during their field trial.

# Study Results

# Primary Test Metrics

The primary metric for clinical performance testing was user-reported (subjective) aided benefit achieved after the field trial of the MDHearing Smart Hearing Aids as assessed using two standard questionnaires (APHAB and SSQ12).

The mean scores and distributions of the reported benefit scores were found to be comparable between the self-fit and professional-fit groups, for the two subjective outcome measures (APHAB and SSQ12 benefit scores) (Figure 2a).

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Image /page/18/Picture/0 description: The image shows the website address "www.MDHearingAid.com". The text is in a clear, sans-serif font and is colored in a dark teal. The background is a gradient of light blue to white, providing a clean and professional look to the website address.

Image /page/18/Picture/1 description: The image contains the logo for MDHearing. The logo consists of a stylized blue wave-like symbol on the left, followed by the text "MDHearing" in a bold, sans-serif font. The color of the text matches the blue of the symbol, creating a cohesive and recognizable brand identity.

Image /page/18/Figure/2 description: The image is a histogram comparing the APHAB Global Benefit Scores of two groups: Pro-fit (N = 29) and Self-fit (N = 30). The x-axis represents the APHAB Global Benefit Score, ranging from 0 to 80, while the y-axis represents the number of participants in each group. The histogram displays the distribution of scores for each group, with black bars representing the Pro-fit group and white bars representing the Self-fit group. The plot shows the number of participants in each group for each APHAB Global Benefit Score.

Figure 2a. Distribution of APHAB Global Benefit scores for the professional-fit (black) and self-fit (white) groups.

Image /page/18/Figure/4 description: This image is a forest plot showing the SSQ Treatment Difference for five different variables: RV, Global, EC, BN, and AV. The x-axis represents the SSQ Treatment Difference, with a vertical line at 0 and another dashed vertical line at -δ. Each variable has a point estimate and a confidence interval represented by a horizontal line. The confidence intervals vary in length, indicating different levels of uncertainty for each variable's treatment effect.

Figure 2b. 95% confidence interval on the difference between self-fit and pro-fit group means for the APHAB. The dashed vertical line shows the non-inferiority margin. If the 95% confidence interval were to extend beyond this boundary, the self-fit scores would be considered inferior to the pro-fit scores on this measure.

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Image /page/19/Picture/1 description: The image shows the logo for MDHearing. The logo consists of a stylized blue wave-like symbol on the left, followed by the text "MDHearing" in a dark blue, sans-serif font. The wave-like symbol appears to be a stylized representation of sound waves, which is relevant to the company's focus on hearing solutions.

Image /page/19/Figure/2 description: The image is a histogram comparing the SSQ12 overall score for two groups: Pro-fit (N = 31) and Self-fit (N = 28). The x-axis represents the SSQ12 overall score, while the y-axis represents the number of participants in each group. The histogram shows the distribution of scores for each group, with black bars representing the Pro-fit group and white bars representing the Self-fit group. The majority of participants in both groups have scores between 0 and 5.

Figure 2c. Distribution of SSQ12 benefit scores for the professional-fit (black) and self-fit (white) groups.

Image /page/19/Figure/4 description: This image is a plot showing the treatment difference. The x-axis is labeled "Treatment Difference" and has tick marks at -δ, 0, and δ. There is a point estimate with a confidence interval that does not cross the 0 line, but does cross the -δ line. There is a vertical dashed line at -δ and a solid vertical line at 0.

Figure 2c. 95% confidence interval on the difference between self-fit and pro-fit group means for the SSQ12. The dashed vertical line shows the non-inferiority margin.

## Secondary Test Metrics and Other Effectiveness Measures:

## Speech-In-Noise Recognition

There was no difference in speech-in-noise intelligibility benefit between the self-fit and the professional-fit groups, as assessed by the QuickSIN, with subjectively comparable score distributions (Figure 3a and 3b ).

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# ) MDHearing

Image /page/20/Figure/2 description: The image shows two histograms comparing QuickSIN Benefit Scores for two groups: Pro-fit (N=29) and Self-fit (N=30). The histograms are separated into two panels labeled "70dBHL" and "MCL". The y-axis represents the proportion of participants in each group, ranging from 0.00 to 0.08, while the x-axis represents the QuickSIN Benefit Score, ranging from -5 to 10.

Figure 3a. Distribution of benefit scores (aided score minus unaided baseline score) for the professional (Pro)-fit (red) and self-fit (blue) groups, for the two presentation levels tested (70 dB HL, left panel; MCL, right panel).

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Image /page/21/Picture/1 description: The image shows the logo for MDHearing. The logo consists of a stylized blue "M" shape on the left, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" shape is made up of curved lines, giving it a fluid and modern appearance.

Image /page/21/Figure/2 description: This image is a forest plot showing the SSQ Treatment Difference for MCL and 70dBHL. The x-axis is labeled "SSQ Treatment Difference" and has tick marks at -δ, 0, and δ. The y-axis has two categories, MCL and 70dBHL. The plot shows the mean and confidence interval for each category.

Figure 3b. 95% confidence interval on the difference between self-fit and pro-fit group means for the QuickSIN. The dashed vertical line shows the non-inferiority margin.

## Reliability and Validity of the MDHearing Self-Fitting Method:

## Real Ear Measures (REMs)

The reliability and validity in-lab (pre- field trial) testing included probe-microphone measures of hearing aid output in the ear canal, expressed either as real ear aided response (REAR) or gain (REAG) depending on the analysis.

Reliability results showed that on successive trials of the self-fitting procedure, the mean absolute difference (MAD) in real-ear measures of average gain was significantly less than 2 dB (p < 0.001) for all trial to trial comparisons (Second - First and Third - Second) and at all test frequencies (Figure 4).

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Image /page/22/Figure/2 description: The image shows two plots side by side, comparing the MAD in gain (dB) between successive measurements at different frequencies. The left plot is labeled "First to Second" and the right plot is labeled "Second to Third". Both plots show data points at frequencies of 500, 1000, 2000, and 4000 Hz, with the MAD in gain ranging from 0 to 4 dB. The MAD in gain is highest at 2000 Hz in the "First to Second" plot.

Figure 4. Mean absolute difference (black symbols) in gain as measured from 500-4000 Hz between successive self-fitting measurements. In-lab reliability testing data were obtained on 44 subjects (N = 88 ears). Error bars are 80% intervals (from 10th percentile to 90th percentile).

As a supplementary, qualitative measure of test-retest reliability of the self-fitting method, average in-lab REAG of a subset of participants (those later assigned to the professional-fit group only) was compared to that measured at baseline during their initial hearing aid fittings. The self-selected gain in the reliability test was similar to the user-preferred, fine-tuned gain of the hearing aid fitting as completed by a clinician. (Figure 5). This was considered an acceptable estimation of test-retest reliability because, for both measu…