(183 days)
No reference devices were used in this submission.
No
The summary does not mention AI, ML, or related terms, and the description of the self-fitting process and performance studies does not indicate the use of these technologies.
Yes
The device is intended to amplify sound for individuals with hearing impairment, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a hearing aid designed to amplify sound for individuals with perceived mild to moderate hearing impairment. Its primary function is therapeutic (to help with hearing) rather than diagnostic (to identify or classify a medical condition). The text explicitly states, "No Pre-programming or hearing test is necessary," further indicating it does not perform a diagnostic function.
No
The device description explicitly states that the system consists of both hardware (Intricon Lumen 200B) and a mobile application. The hardware component includes microphones, a receiver, and is encased in a physical hearing aid body.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The MDHearing Smart Hearing Aid is a hearing aid. Its function is to amplify sound to compensate for hearing loss. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to amplify sound for individuals with perceived mild to moderate hearing impairment. This is a therapeutic/compensatory function, not a diagnostic one.
The information provided clearly describes a hearing aid, which falls under a different category of medical devices than IVDs.
N/A
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.
Product codes
QDD
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Direct-to-consumer sale and use without the assistance of a hearing care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Sixty-four adults aged 18 years or older with sensorineural hearing from mild to moderate degree completed this study.
Data source appears to be the clinical study conducted for this specific device.
Annotation protocol:
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.
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.
Summary of Performance Studies
Study Type: Randomized clinical validation study comparing self-fit vs. professional-fit outcomes.
Sample Size: 64 adults (32 in Self-Fit group, 32 in Professional-Fit group). N=88 ears for in-lab reliability testing.
Standalone Performance: The MDHearing Smart Hearing Aid system was evaluated for its self-fitting capability and overall performance.
Key Results:
- User-reported (subjective) aided benefit: Mean scores and distributions from APHAB and SSQ12 were comparable between self-fit and professional-fit groups.
- Speech-In-Noise Recognition: No significant difference in intelligibility benefit between self-fit and professional-fit groups as assessed by QuickSIN.
- Reliability and Validity of Self-Fitting: Mean Absolute Difference (MAD) in real-ear measures of average gain was significantly less than 2 dB for successive self-fitting measurements, demonstrating reliability. Self-selected gain was similar to user-preferred, fine-tuned gain from professional fitting.
- Safety: No adverse events or serious adverse events reported during the clinical study.
- Effectiveness: The MDHearing Smart Hearing Aid was non-inferior to fitting by a hearing care professional for both subjective and objective measures of hearing aid benefit, demonstrating substantial equivalence to the predicate device.
Key Metrics
- APHAB Global Benefit Scores
- SSQ12 benefit scores / overall score
- QuickSIN Benefit Scores
- Mean absolute difference (MAD) in real-ear measures of average gain
- Real Ear Aided Response (REAR) or gain (REAG)
Predicate Device(s)
Bose® Hearing Aid (DEN180026)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary - K220303
. SUBMITTER
MDHearingAid 150 N. Michigan Avenue Suite 400 Chicago, IL 60601
Contact Person: Doug Breaker Phone: 844-944-3277 Fax: 312-598-1068
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
4
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.
5
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
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | The Bose Hearing Aid is
intended to amplify sound for
individuals 18 years of age or
older with perceived mild to
moderate hearing impairment. It
is 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 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. | The Indications for Use and
intended users are the same. |
| Technology | Wireless, self-fitting
air-conduction hearing aid | Wireless, self-fitting
air-conduction hearing aid | Same |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| Housing | Hearing aid neckband housing
that connects to both the left and
right ear units with user controls
on right earbud wire
Image: Bose Hearing Aid | Traditional behind-the-ear
(BTE) form factor
Image: MDHearing Smart Hearing Aid | Although the subject device
hearing aid housing is
wireless and BTE instead of
a neckband with wired
earbuds, the difference in
housing does not raise
different questions of safety
or effectiveness.
Non-clinical and clinical
performance testing and
validation data, including
usability and safety testing,
support substantial
equivalence. |
| Wireless communication | Wireless communication with
handheld device via Bluetooth | Wireless communication with
handheld device via
Bluetooth | Same |
| Wireless control functions via
mobile application | -Volume control
-Modes (everywhere, front,
focused)
-Tone correction
-Left/Right balance | -Volume control (can adjust
overall or R/L individually)
-Programs ("Automatic",
"Quiet", "Conversation",
"Restaurant")
-Equalizer for Low-, Mid-,
and High-tones
-Noise reduction
-Directionality | The additional wireless
control functions supported
for the subject device do not
raise different questions of
safety or effectiveness.
Non-clinical and clinical
performance testing and
validation data, including
usability and safety testing,
support substantial
equivalence. |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| Device control | On-Device user controls:
- Volume up/down microphone
- Volume up/down streaming
- Power on/off button
- Bluetooth pairing button | On-Device user controls:
-Volume up/down
-Program up/down
-Power on/off (via hearing
aid battery door closed or
open) | Sound adjustment controls
are similar. Powering off/on
and Bluetooth pairing mode
for the subject device are
controlled by opening/closing
battery door. The subject
device does not support
streaming, so the absence of
those controls, and the
different means of engaging
Bluetooth and turning the
device on/off, do not raise
different questions of safety
or effectiveness.
Non-clinical and clinical
performance testing and
validation data, including
usability and safety testing,
support substantial
equivalence. |
| Mobile App | Mobile application, on handheld
device (iOS or Android) used to
configure parameters, settings,
and listening modes | Mobile application, on
handheld device (iOS or
Android) used to configure
parameters, settings, and
listening modes | Same |
| Battery | Single cell rechargeable
3.7V/270mAh li-ion battery inside
neckband | Replaceable, disposable,
1.3Vdc zinc-air hearing aid
battery (size 312) | Other legally marketed
hearing aids (including those
exempt from 510(k) fitted by
hearing care professionals) |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| | | | also utilize disposable
zinc-air size 312 hearing aidbatteries. As such, the
difference in power source
does not raise different
questions of safety or
effectiveness.
Non-clinical and clinical
performance testing and
validation data, including
usability and safety testing,
support substantial
equivalence. |
| Microphones | Microphones in earbud may,
during use, be configured by the
user in omnidirectional or
directional modes. | Microphones on hearing aid
body may, during use, be
configured by the user in
omnidirectional or directional
modes. | Both the subject device and
the predicate device allow for
omnidirectional and speech
focus options.
The subject device supports
an adaptive directional mode
that allows the hearing aids
to determine the most
suitable directionality for the
microphones for the given
environment.
The added automatic
selection of directionality
does not raise different
questions of safety or |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| | | | effectiveness. |
| Compression | 12 channel wide band dynamic
range compression | 8 channel wide band
dynamic range compression | The difference in the number
of channels is
inconsequential for achieving
adequate spectral tilt, with
both subject and predicate
devices having 12 gain
adjustment bands, and this
|
| Noise reduction | Active noise reduction, steady
state noise reduction, impulse
noise control | 12-channel layered noise
reduction | While differences in the
implementation of noise
reduction exist, these do not
raise different questions of
safety or effectiveness.
Non-clinical and clinical
performance testing and
validation data support
substantial equivalence. |
| Feedback cancellation | Feedback canceller | Adaptive feedback
cancellation | Same |
| Self-fitting method | Loudness and Fine-Tuning. | Apply personalized gain | Instead of a proprietary |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| | Utilizes a proprietary fitting
algorithm. | settings based on user input
and fine-tuning. Utilizes
NAL-NL2 fitting algorithm. | algorithm as used by the
predicate device, subject
device uses the validated
NAL-NL2 fitting algorithm,
widely used by hearing care
professionals to fit persons
with mild to moderate
hearing loss.
Legally marketed hearing
aids exempt from 510(k) also
embed the NAL-NL2 fitting
algorithm, but these exempt
hearing aids are fitted by
hearing care professionals.
As such the difference in
fitting strategy does not raise
different questions of safety
or effectiveness.
Data from a clinical
validation study support
substantial equivalence. |
| Remote firmware update | Unknown | Remote firmware update via
cloud-based solutions with
the MDHearing app | Remote firmware update
allows MDHearing to
maintain and improve Smart
hearing aids and strengthen
cybersecurity as new mobile
operating systems are
released. This is assessed
as part of the cybersecurity |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| | | | risk assessment, and this
feature does not raise
different questions of safety
or effectiveness. |
| Wireless coexistence | The Bose BMD-001 Hearing Aid
uses standard 2.4GHz Classic
Bluetooth and Bluetooth Low
Energy (BLE) standards to
communicate between the
hearing aid and the user's
Bluetooth enabled device. From
the risk assessment, the
temporary loss of Bluetooth
communication from interfering
RF signals is appropriately
considered a negligible risk and
according to AAMI TIR 69,
wireless coexistence testing is
not required. | The MDHearing Smart
(Intricon Lumen200B)
Hearing Aid uses the same
standard 2.4GHz Classic
Bluetooth and Bluetooth Low
Energy (BLE) standards as
the predicate to
communicate between the
hearing aid and the user's
Bluetooth enabled device.
Wireless coexistence testing
is not required per AAMI TIR
69. | Same |
| Electroacoustic parameters
(special control 2) | Maximum output limits, distortion
levels, self-generated noise
levels, latency, full on gain,
frequency response, and other
parameters as required per 21
CFR 874.3325(b)(2)
demonstrated to perform to
specifications of ANSI
S3.22:2014 and ANSI CTA
2051:2017 standards. | Maximum output limits,
distortion levels,
self-generated noise levels,
latency, full on gain,
frequency response, and
other parameters as required
per 21 CFR 874.3325(b)(2)
demonstrated to perform to
specifications of ANSI
S3.22:2014 and ANSI CTA
2051:2017 standards. | Same
See Non-Clinical
Performance Testing
summary ANSI comparison
table. |
| Characteristic | Predicate Device: Bose
Hearing Aid (DEN180026) | Subject Device:
MDHearing Smart Hearing
Aid | Discussion |
| Exposure to nonionizing
radiation (special control 5i) | The Bose Hearing Aid contains a
Bluetooth radio transmitter
operating in the ISM band (2.400
to 2.4835 GHz) at less than 10
mW EIRP. The output power
level at these operating
frequencies of the Bose Hearing
Aid was deemed sufficiently safe
in terms of human exposure to
nonionizing radiation for the
intended use. | The equipment operates in
the ISM 2.4 GHz band (2.40
- 2.4835 GHz), using the
Bluetooth® SMART protocol,
and the maximum RF Power
transmitted in that band is
-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.
12
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.
13
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.
14
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 | |
| 18 to 39 years of age | |
| 40 to 49 years of age | |
| 50 to 59 years of age | |
| 60 to 69 years of age | |
| 60 to 79 years of age | 5 / 64 (8%) |
| 8 / 64 (13%) | |
| 13 / 64 (19%) | |
| 22 / 64 (35%) | |
| 16 / 64 (25%) | |
| Sex | |
| Female | |
| Male | 36 / 64 (57%) |
| 28 / 64 (43%) | |
| Hearing Loss Degree | |
| Mild | |
| Mild to Moderate | 15 / 64 (24%) |
| 49 / 64 (76%) | |
| Hearing Aid Use | |
| Experienced | |
| New | 40 / 64 (63%) |
| 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.
17
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 ).
20
) 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 8000 Hz | 200 Hz to 7000 Hz | Comparable to the
predicate and
suitable for the
intended user.
Both in
conformity to
ANSI/CTA-2051. |
| Harmonic Distortion
ANSI S3.22:2014
(6.11) | 3.6% | 500 Hz 3%
800 Hz 1%
1600 Hz 0%
THD ≤ 5% | Both in
conformity to
ANSI/CTA-2051. |
| EIN
ANSI S3.22:2014
(6.12) | 26 dB SPL | 24 dB SPL | Both in
conformity to
ANSI/CTA-2051. |
| Battery Current
ANSI S3.22:2014
(6.13) | N/A | 1.2 mA | Predicate device was
rechargeable. |
| Estimated Battery | N/A** | Under normal | |
| Test Specification
Applicable Standard
(Clause) | Predicate Device:
Bose Hearing Aid
(DEN180026)* | Subject Device:
MDHearing Smart
Hearing Aid | Discussion |
| Life
ANSI/CTA 2051:2017
(4.7) | | operating conditions
the size 312 battery
lasts around 100
hours prior to
replacement. | In conformity to
ANSI/CTA-2051. |
| Latency
ANSI/CTA 2051:2017
(4.8) | ≤ 15ms** | ≤ 15ms | Both in
conformity to
ANSI/CTA-2051. |
| Reporting of
Hearing Aid
Features
ANSI/CTA 2051:2017
(4.10-4.17) | N/A** | -Fixed or Level
Dependent
Frequency
Equalization
-Level Dependent
-Gain/Compression
-SNR Enhancement
-Noise Reduction
-Feedback Control/
Cancellation
-Personalization
-Device Coupling to
the Ear
-Wireless
Connectivity | In conformity to
ANSI/CTA-2051. |
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Image /page/28/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized blue wave-like graphic on the left, followed by the text "MDHearing" in a bold, dark blue font. The text is positioned to the right of the graphic, creating a unified brand identity.
510(k) Summary - K220303
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Image /page/29/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized blue wave-like graphic on the left, followed by the text "MDHearing" in a bold, dark blue font. The wave graphic appears to be a stylized representation of sound waves, and the text is clear and legible.
- The information presented in this table for the predicate Bose Hearing Aid (DEN180026) is as it is reported in K211008 unless otherwise noted.
**Performance of predicate device on this parameter is not publicly available – De Novo Summary for the predicate Bose® Hearing Aid (DEN180026) reports only a test result of "Pass" (per ANSI/CTA-2051) or "Complete" (for parameters with only a reporting requirement and not a performance requirement).
30
Image /page/30/Figure/2 description: The image is a graph that compares the dB SPL and Frequency (Hz) of ANSI S3.22-2003 and IEC118-7-2005 with IEC118-0 OES. The x-axis represents frequency in Hz, ranging from 100 to 10000, while the y-axis represents dB SPL, ranging from 60 to 130. The graph shows two lines, one representing ANSI S3.22-2003 and IEC118-7-2005 and the other representing IEC118-0 OES.
Figure 7. Nominal OSPL90 (blue) and frequency response (purple) curves for MDHearing Smart Hearing Aid as measured in 2cc coupler. Note: ANSI S3.22 and IEC 60118-7 standard specifications are technically equivalent for the electroacoustic parameters required as special controls.
The results of all performance testing required as special controls demonstrated substantial equivalence of the MDHearing Smart Hearing Aid to the predicate Bose Hearing Aid. The MDHearing Smart Hearing Aid has the same intended use and fundamental technology as the predicate. The differences in technological characteristics do not raise different questions of safety or effectiveness.
Usability Testing:
In order to evaluate the usability and safety of the MDHearing Smart Hearing Aid, a human factors study was conducted with 20 untrained participants representing the intended user population of the devices (individuals 18 years of age or older with perceived mild to moderate hearing impairment). This study was conducted in accordance with FDA's quidance. Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff (2016). The overall aim of the human factors study was to qualitatively assess a population of representative users' ability to safely operate the MDHearing Smart Hearing Aids and app without any assistance from a hearing care professional.
Each participant was provided a pair of MDHearing Smart Hearing Aids, new in the box, with all standard accessories and user manuals for the devices included, and experimenters observed and assessed participants' completion of the following hands-on use tasks:
- Unbox the MDHearing Smart Hearing Aids ●
- Download the MDHearing app to personal smartphone.
- Register for the app. ●
- Place batteries in the hearing aids.
31
MDHearing
- Use the app to pair the hearing aids to the smartphone via Bluetooth.
- Use the app to take the personalization profile.
- Use the app to adjust the volume, program, noise reduction, microphone direction, bass, ● treble, and mid pitched settings.
- Turn off the hearing aids. .
A self-identification questionnaire, designed to evaluate participants' general knowledge regarding hearing health issues and the circumstances under which it may be appropriate to seek help from a professional, was completed as part of the study procedure. Participants' ability to self-fit the hearing aids using the app and to achieve a proper physical fit of the devices with included ear tips was also observed as part of the above hands-on use scenarios.
The results of the human factors validation testing showed that the MDHearing Smart Hearing Aids are safe and operable for intended users, uses, and use environments.
XI. CYBERSECURITY
The MDHearing Smart Hearing Aids and the Intricon-provided cloud based fitting solution was determined to have appropriate safety tools and controls such that the risk of a security breach is negligible. The risks are acceptable and reduced as far as possible.
The MDHearing app and cloud-based application was determined to have appropriate safety tools and controls such that the risk of a cybersecurity breach is negligible. The risks are acceptable and reduced as far as possible.
Due to the negligible risk, no special labeling is deemed necessary regarding cybersecurity controls in the instructions for use. The labeling in the instructions for use is appropriate for the intended use environment, which is an at-home environment.
Due to negligible risk, no special product specifications related to cybersecurity controls are needed.
XII. CONCLUSION
The MDHearing Smart Hearing Aid is substantially equivalent in intended use to the Bose® Hearing Aid (DEN180026). The non-clinical testing and performance data verify the safety and effectiveness of the subject device, and the hardware and software verification and validation demonstrate that the MDHearing Smart Hearing Aid should perform as intended in the specified use conditions. The human factors study demonstrated that the usability of the MDHearing Smart Hearing Aid was analyzed, verified, and validated for its intended use, and the implemented mitigations for user training and device labeling are adequate. The clinical data showed similar results in subjective and objective measures between subjects who self-fit and were professionally fit with the MDHearing Smart Hearing Aid. The clinical data validates that the MDHearing Smart Hearing Aid performs comparably to the predicate device, the Bose® 510(k) Summary - K220303
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Image /page/32/Picture/0 description: The image contains the logo for MDHearing. The logo consists of a stylized blue letter "M" on the left, followed by the text "MDHearing" in a bold, dark blue font. The "M" is designed with a flowing, wave-like appearance.
Hearing Aid as outlined in DEN180026. Together, these performance data support that the MDHearing Smart Hearing Aid is substantially equivalent in intended use to the predicate device, the Bose® Hearing Aid (DEN180026), and is as safe and as effective for its intended use when used in accordance with its Instructions for Use.