(183 days)
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-to-consumer sale and use without the assistance of a hearing care professional.
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 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 provided text describes the MDHearing Smart Hearing Aid and the studies conducted to demonstrate its substantial equivalence to a predicate device (Bose® Hearing Aid). The primary focus of the clinical performance testing was to show that self-fitting the device produced outcomes non-inferior to a professional fitting.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The clinical performance validation aimed to demonstrate non-inferiority of the self-fit MDHearing Smart Hearing Aid compared to the same device professionally fit. The primary test metrics were user-reported (subjective) aided benefit using two standard questionnaires: the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the 12-item short form of the Speech, Spatial and Qualities of Hearing scale (SSQ12). A secondary metric was speech-in-noise recognition using the QuickSIN test.
The text states: "The study results demonstrated that 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."
The specific acceptance criteria (e.g., non-inferiority margins) are not explicitly stated as numerical thresholds in this document, but the graphical representations (Figure 2b and Figure 3b) show confidence intervals relative to a non-inferiority margin (-δ). The conclusion is that these intervals did not extend beyond the non-inferiority boundary.
Table of Acceptance Criteria and Reported Device Performance (Summary based on text):
| Acceptance Criteria (Implicit from study design for Non-Inferiority) | Reported Device Performance |
|---|---|
| Primary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (APHAB Global Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2a and 2b) |
| Non-inferiority of Self-Fit vs. Professional-Fit on Subjective Aided Benefit (SSQ12 Benefit Scores) | Mean scores and distributions comparable between self-fit and professional-fit groups. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 2c and 2d) |
| Secondary Endpoints: | |
| Non-inferiority of Self-Fit vs. Professional-Fit on Speech-In-Noise Recognition (QuickSIN) | No difference in speech-in-noise intelligibility benefit between self-fit and professional-fit groups, with subjectively comparable score distributions. 95% confidence interval for the difference between self-fit and pro-fit group means did not extend beyond the non-inferiority margin, indicating non-inferiority. (Reference Fig. 3a and 3b) |
| Reliability of self-fitting method (Probe-Microphone Real Ear Measures - REAG) | Mean absolute difference (MAD) in real-ear measures of average gain significantly less than 2 dB (p < 0.001) for all trial-to-trial comparisons and test frequencies, demonstrating reliability and validity. (Reference Fig. 4) |
| Capable of delivering adequate amplification (REAR approximation to NAL-NL2 targets by professional-fit) | Reasonable approximation of REAR to prescribed target levels (NAL-NL2), demonstrating capability for compensation for mild to moderate hearing loss. (Reference Fig. 6) |
| User safety and operability (Human Factors Study) | Safe and operable for intended users, uses, and use environments. |
| Electrocacoustic Performance (ANSI ASA S3.22:2014 & ANSI CTA 2051:2017) | All tested parameters (OSPL90 curve, MAX OSPL90, HFA-OSPL90, HFA FOG, RTG, Frequency response, bandwidth, Harmonic Distortion, EIN, Battery Current, Latency, Features) are comparable to predicate, suitable for intended user, and/or conform to standards. (Reference Table on page 27-28 and Fig 7) |
| Cybersecurity Risk | Negligible. Appropriate safety tools and controls in place. |
| Basic Safety and Essential Performance / Electromagnetic Compatibility / Biocompatibility / Usability / Risk Management / Wireless Coexistence / RF Immunity (various IEC, ISO, FDA standards) | All standards passed. (Reference Table on page 25) |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Clinical Performance Study (RCT):
- Total participants: 64 adults (18 years or older with sensorineural hearing loss from mild to moderate degree).
- Randomized 1:1 into two groups: 32 in "Professional-Fit" group and 32 in "Self-Fit" group.
- Data provenance: Single-site clinical validation study. The country is not explicitly stated, but it's an FDA submission, implying a US study. The study was prospective ("randomized clinical validation study").
- Reliability and Validity of Self-Fitting (in-lab):
- 44 subjects (N = 88 ears) for the reliability measures (MAD in gain).
- 58 ears (subset of professional-fit group) for comparison of user-preferred vs. clinician fine-tuned gain.
- N=56 ears (28 participants) for REAR matching to NAL-NL2 targets.
- Human Factors Study:
- 20 untrained participants representing the intended user population.
- Electroacoustic Performance (Non-Clinical):
- Testing performed on the device itself, not on human subjects.
- Clinical Performance Study (RCT):
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Professional-Fit" arm of the clinical study, a clinician (presumably an audiologist or hearing care professional) programmed and fine-tuned the hearing aids "according to audiologic standards of care." The exact number and specific qualifications (e.g., years of experience) of these clinicians are not provided, only that they were "hearing care professionals" and "clinicians." Given it's a "single site" study, it likely involved a limited number of professionals.
- For the self-fit group, the "ground truth" for comparison was the professional-fit group's performance. The subjective and objective outcome measures themselves served as a form of "ground truth" to compare the two fitting methods.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this hearing aid study. This type of adjudication is typically used for image-based diagnostic studies where human readers evaluate image findings and reach a consensus. Here, the outcome measures are quantitative (questionnaire scores, QuickSIN, real-ear measures) or direct observation of user interaction (human factors). The "professional-fit" outcome served as a benchmark, not an adjudicated ground truth in the sense of expert consensus on an interpretation.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC study was not conducted. This was a randomized controlled trial comparing two fitting methods (self-fit vs. professional-fit) for a hearing aid, not an AI-assisted diagnostic task involving human readers. The "AI" component is the self-fitting algorithm within the device and app. The language used (effect size of human readers improving with AI) is typically for AI in diagnostic imaging.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "self-fitting" mechanism itself is the core of the algorithm's standalone performance in providing an initial fit and allowing user adjustments. The clinical study implicitly evaluates this by comparing outcomes of the "self-fit" group (who primarily relied on the algorithm and their own adjustments) to the "professional-fit" group.
- The "Reliability and Validity of the MDHearing Self-Fitting Method" section described in-lab testing where probe-microphone measures were taken after user adjustments, evaluating the consistency and approximation of the self-selected gain to professionally selected targets (NAL-NL2), this could be considered a form of evaluating the algorithm's output through user interaction.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for the clinical comparison was the outcomes data from the "professional-fit" group, which served as the benchmark for demonstrating non-inferiority.
- Subjective Outcomes: Patient-reported measures (APHAB, SSQ12).
- Objective Outcomes: Speech-in-noise recognition (QuickSIN) and Real Ear Measures (REMs) against prescribed NAL-NL2 targets (an audiologic standard).
- For the human factors study, the ground truth was the observed ability of participants to safely and correctly operate the device and app, guided by pre-defined task completion criteria.
- The primary ground truth for the clinical comparison was the outcomes data from the "professional-fit" group, which served as the benchmark for demonstrating non-inferiority.
-
The sample size for the training set:
- The document does not explicitly state a separate training set size for the self-fitting algorithm. The NAL-NL2 fitting formula, which the device utilizes, is a well-established, validated prescriptive algorithm for hearing aid fitting, developed based on extensive audiological research and data. It's not a machine learning model that's "trained" in the typical sense on a specific dataset for this device. The app personalizes settings based on user input, which then applies this pre-established NAL-NL2 formula for the initial fit.
-
How the ground truth for the training set was established:
- As noted above, the device uses the NAL-NL2 fitting formula, which is a widely accepted audiological standard, not a data-trained algorithm in the modern AI sense. Therefore, there wasn't a "training set" for this specific device's algorithm that required establishing ground truth by human experts. The "ground truth" for NAL-NL2 itself comes from decades of audiological research and clinical consensus on optimal gain targets for speech intelligibility. The device "applies personalized gain settings based on user input and fine-tuning. Utilizes NAL-NL2 fitting algorithm."
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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
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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 (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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| 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: 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
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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: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
|---|---|---|---|
| Indications For Use | The Bose Hearing Aid isintended to amplify sound forindividuals 18 years of age orolder with perceived mild tomoderate hearing impairment. Itis adjusted by the user to meetthe user's hearing needs. Nopre-programming or hearing testis necessary. The device isintended for direct-to-consumersale and use without theassistance of a hearing careprofessional. | The MDHearing SmartHearing Aids are self-fittingair-conduction hearing aids,intended to amplify sound forindividuals 18 years of ageor older with perceived mildto moderate hearingimpairment. They areadjusted by the user to meetthe user's hearing needs. Nopre-programming or hearingtest is necessary. The deviceis intended fordirect-to-consumer sale anduse without the assistance ofa hearing care professional. | The Indications for Use andintended users are the same. |
| Technology | Wireless, self-fittingair-conduction hearing aid | Wireless, self-fittingair-conduction hearing aid | Same |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| Housing | Hearing aid neckband housingthat connects to both the left andright ear units with user controlson right earbud wireImage: Bose Hearing Aid | Traditional behind-the-ear(BTE) form factorImage: MDHearing Smart Hearing Aid | Although the subject devicehearing aid housing iswireless and BTE instead ofa neckband with wiredearbuds, the difference inhousing does not raisedifferent questions of safetyor effectiveness.Non-clinical and clinicalperformance testing andvalidation data, includingusability and safety testing,support substantialequivalence. |
| Wireless communication | Wireless communication withhandheld device via Bluetooth | Wireless communication withhandheld device viaBluetooth | Same |
| Wireless control functions viamobile application | -Volume control-Modes (everywhere, front,focused)-Tone correction-Left/Right balance | -Volume control (can adjustoverall or R/L individually)-Programs ("Automatic","Quiet", "Conversation","Restaurant")-Equalizer for Low-, Mid-,and High-tones-Noise reduction-Directionality | The additional wirelesscontrol functions supportedfor the subject device do notraise different questions ofsafety or effectiveness.Non-clinical and clinicalperformance testing andvalidation data, includingusability and safety testing,support substantialequivalence. |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | 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 hearingaid battery door closed oropen) | Sound adjustment controlsare similar. Powering off/onand Bluetooth pairing modefor the subject device arecontrolled by opening/closingbattery door. The subjectdevice does not supportstreaming, so the absence ofthose controls, and thedifferent means of engagingBluetooth and turning thedevice on/off, do not raisedifferent questions of safetyor effectiveness.Non-clinical and clinicalperformance testing andvalidation data, includingusability and safety testing,support substantialequivalence. |
| Mobile App | Mobile application, on handhelddevice (iOS or Android) used toconfigure parameters, settings,and listening modes | Mobile application, onhandheld device (iOS orAndroid) used to configureparameters, settings, andlistening modes | Same |
| Battery | Single cell rechargeable3.7V/270mAh li-ion battery insideneckband | Replaceable, disposable,1.3Vdc zinc-air hearing aidbattery (size 312) | Other legally marketedhearing aids (including thoseexempt from 510(k) fitted byhearing care professionals) |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| also utilize disposablezinc-air size 312 hearing aidbatteries. As such, thedifference in power sourcedoes not raise differentquestions of safety oreffectiveness.Non-clinical and clinicalperformance testing andvalidation data, includingusability and safety testing,support substantialequivalence. | |||
| Microphones | Microphones in earbud may,during use, be configured by theuser in omnidirectional ordirectional modes. | Microphones on hearing aidbody may, during use, beconfigured by the user inomnidirectional or directionalmodes. | Both the subject device andthe predicate device allow foromnidirectional and speechfocus options.The subject device supportsan adaptive directional modethat allows the hearing aidsto determine the mostsuitable directionality for themicrophones for the givenenvironment.The added automaticselection of directionalitydoes not raise differentquestions of safety or |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| effectiveness. | |||
| Compression | 12 channel wide band dynamicrange compression | 8 channel wide banddynamic range compression | The difference in the numberof channels isinconsequential for achievingadequate spectral tilt, withboth subject and predicatedevices having 12 gainadjustment bands, and this |
| Noise reduction | Active noise reduction, steadystate noise reduction, impulsenoise control | 12-channel layered noisereduction | While differences in theimplementation of noisereduction exist, these do notraise different questions ofsafety or effectiveness.Non-clinical and clinicalperformance testing andvalidation data supportsubstantial equivalence. |
| Feedback cancellation | Feedback canceller | Adaptive feedbackcancellation | Same |
| Self-fitting method | Loudness and Fine-Tuning. | Apply personalized gain | Instead of a proprietary |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| Utilizes a proprietary fittingalgorithm. | settings based on user inputand fine-tuning. UtilizesNAL-NL2 fitting algorithm. | algorithm as used by thepredicate device, subjectdevice uses the validatedNAL-NL2 fitting algorithm,widely used by hearing careprofessionals to fit personswith mild to moderatehearing loss.Legally marketed hearingaids exempt from 510(k) alsoembed the NAL-NL2 fittingalgorithm, but these exempthearing aids are fitted byhearing care professionals.As such the difference infitting strategy does not raisedifferent questions of safetyor effectiveness.Data from a clinicalvalidation study supportsubstantial equivalence. | |
| Remote firmware update | Unknown | Remote firmware update viacloud-based solutions withthe MDHearing app | Remote firmware updateallows MDHearing tomaintain and improve Smarthearing aids and strengthencybersecurity as new mobileoperating systems arereleased. This is assessedas part of the cybersecurity |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| risk assessment, and thisfeature does not raisedifferent questions of safetyor effectiveness. | |||
| Wireless coexistence | The Bose BMD-001 Hearing Aiduses standard 2.4GHz ClassicBluetooth and Bluetooth LowEnergy (BLE) standards tocommunicate between thehearing aid and the user'sBluetooth enabled device. Fromthe risk assessment, thetemporary loss of Bluetoothcommunication from interferingRF signals is appropriatelyconsidered a negligible risk andaccording to AAMI TIR 69,wireless coexistence testing isnot required. | The MDHearing Smart(Intricon Lumen200B)Hearing Aid uses the samestandard 2.4GHz ClassicBluetooth and Bluetooth LowEnergy (BLE) standards asthe predicate tocommunicate between thehearing aid and the user'sBluetooth enabled device.Wireless coexistence testingis not required per AAMI TIR69. | Same |
| Electroacoustic parameters(special control 2) | Maximum output limits, distortionlevels, self-generated noiselevels, latency, full on gain,frequency response, and otherparameters as required per 21CFR 874.3325(b)(2)demonstrated to perform tospecifications of ANSIS3.22:2014 and ANSI CTA2051:2017 standards. | Maximum output limits,distortion levels,self-generated noise levels,latency, full on gain,frequency response, andother parameters as requiredper 21 CFR 874.3325(b)(2)demonstrated to perform tospecifications of ANSIS3.22:2014 and ANSI CTA2051:2017 standards. | SameSee Non-ClinicalPerformance Testingsummary ANSI comparisontable. |
| Characteristic | Predicate Device: BoseHearing Aid (DEN180026) | Subject Device:MDHearing Smart HearingAid | Discussion |
| Exposure to nonionizingradiation (special control 5i) | The Bose Hearing Aid contains aBluetooth radio transmitteroperating in the ISM band (2.400to 2.4835 GHz) at less than 10mW EIRP. The output powerlevel at these operatingfrequencies of the Bose HearingAid was deemed sufficiently safein terms of human exposure tononionizing radiation for theintended use. | The equipment operates inthe ISM 2.4 GHz band (2.40- 2.4835 GHz), using theBluetooth® SMART protocol,and the maximum RF Powertransmitted 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.
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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 (%) |
|---|---|
| Age18 to 39 years of age40 to 49 years of age50 to 59 years of age60 to 69 years of age60 to 79 years of age | 5 / 64 (8%)8 / 64 (13%)13 / 64 (19%)22 / 64 (35%)16 / 64 (25%) |
| SexFemaleMale | 36 / 64 (57%)28 / 64 (43%) |
| Hearing Loss DegreeMildMild to Moderate | 15 / 64 (24%)49 / 64 (76%) |
| Hearing Aid UseExperiencedNew | 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.
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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 measures, the subjective "target" of comfortable loudness and sound quality was the same.
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Image /page/23/Picture/1 description: The image shows the logo for MDHearing. The logo consists of a stylized blue letter "M" on the left, followed by the text "MDHearing" in a dark blue sans-serif font. The "M" is designed with a flowing, wave-like appearance.
Image /page/23/Figure/2 description: The figure shows REAG (dB) on the y-axis and Frequency (Hz) on the x-axis. The plot shows two lines, one for Professional Fine Tuning (N = 58 ears) and one for User Fine Tuning (N = 58 ears). The x-axis has values of 500, 1000, and 3000. The y-axis ranges from -15 to 5.
Figure 5. Average REAG from 500-4000 Hz of user-preferred settings as measured during professional-fitting (red) and as self-fit for the in-lab reliability testing procedure (blue). Error bars represent ± 1 standard deviation.
Lastly, analysis of professional-fit participants' real-ear hearing aid output at the time of their initial hearing aid field trial fitting revealed reasonable approximation of REAR to prescribed target levels as measured from 500-4000 Hz, demonstrating that the MDHearing Smart Hearing Aids are capable of delivering adequate amplification to compensate for mild to moderate hearing loss (Figure 6).
Image /page/23/Figure/5 description: The figure displays a plot of output in dB SPL versus frequency in Hz. There are two data series plotted: "Measured REAR" and "NAL - NL2 target". The x-axis shows the frequency values of 500, 1000, and 3000 Hz. The y-axis shows the output values ranging from 60 to 90 dB SPL. The plot shows that the NAL-NL2 target is higher than the measured REAR at all frequencies.
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Figure 6. Mean (black symbols) and ± 95% confidence interval (error bars) of the REAR measured when matching to NAL-NL2 prescriptive targets (blue symbols) for average (65 dB SPL) conversational speech input. Targets shown are representative of those based on the average audiometric thresholds at 500, 1000, 2000, and 4000 Hz for the analyzed ears (N=56) of the 28 participants included in this analysis.
Taken together, the baseline REM results of the laboratory reliability testing self-fit procedure and of the professionally derived, target-matched aided response curves (Figures 4-6 above) for a subset of participants fit by a clinician with the MDHearing Smart Hearing Aids demonstrate both reliability and validity of the MDHearing self-fitting method. The final REMs of user-preferred, field-selected hearing aid settings for all participants were analyzed and found to be similar between groups.
Effectiveness
The MDHearing Smart Hearing Aids clinical study focused on determining an equivalence in performance between a fitting by the user of the subject device and a fitting by a hearing care professional. Using methods similar to those used to validate the predicate device, the outcomes compared subjective and objective benefit with the MDHearing Smart Hearing Aids through both quantitative and qualitative measures. The study results demonstrated that 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.. Therefore, the effectiveness of the MDHearing Smart Hearing Aid as a self-fitting, air conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment, without the assistance of a hearing care professional, is substantially equivalent to the effectiveness reported for the predicate device, the Bose® Hearing Aid (DEN180026).
Safety
There were no adverse events or serious adverse events reported during the clinical study.
Summary
The MDHearing Smart Hearing Aid was evaluated in a clinical study using both subjective and objective measures commonly used to validate the performance of hearing aid systems and the benefit associated with the hearing aid to the individual user. The results of clinical performance testing provide support for the conclusion that the MDHearing Aid has a reliable self-fitting method and will provide the intended user population with functional aided performance not inferior to that provided by a professional hearing aid fitting.
X. NON-CLINICAL PERFORMANCE TESTING
Non-clinical performance testing, including human factors testing, was conducted to demonstrate substantial equivalence and to provide reasonable assurance of safety and
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Image /page/25/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 darker blue font. The letter "M" is designed with curved lines, giving it a modern and fluid appearance.
effectiveness as compared to the predicate device, the Bose® Hearing Aid, as described in DEN180026. The standards used and results of non-clinical performance testing are summarized in the table below.
Summary of Non-Clinical Performance Testing
| Applicable Standard(s) / FDA Guidance | Test Purpose | Result |
|---|---|---|
| IEC 60601-1:2005 Medical electrical equipment - Part 1:General requirements for basic safety and essentialperformance | Basic Safety andEssential Performance | |
| IEC 60601-1-11:2010 – Medical electrical equipment - Part1-11: General requirements for basic safety and essentialperformance - Collateral standard: Requirements for medicalelectrical equipment and medical electrical systems used inthe home healthcare environment | Pass | |
| IEC 60601-2-66:2013 Medical electrical equipment – Part2-66: Particular requirements for the basic safety andessential performance of hearing instruments and hearinginstrument systems | ||
| IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance – Collateral Standard: Electromagneticdisturbances - Requirements and tests | ElectromagneticCompatibility (EMC) | Pass |
| IEC 60118-13:2019 - Electroacoustics - Hearing aids – Part13: Electromagnetic compatibility | ||
| IEC 62304:2006/AMD 1:2015 00 Medical device software –Software life cycle processes – Amendment 1 | SoftwareVerification/Validation | |
| ISO 13485:2016 Medical devices – Quality managementsystems - Requirements for regulatory purposes | Pass | |
| FDA-2020-D-0957 (2005) | ||
| ISO 10993-1:2018 Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk managementprocess | Biocompatibility | |
| ISO 10993-5:2009 Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity | Pass | |
| ISO 10993-10:2010 Biological evaluation of medical devices –Part 10: Tests for irritation and skin sensitization | ||
| Applicable Standard(s) / FDA Guidance | Test Purpose | Result |
| ISO 10993-12:2007 Biological evaluation of medical devices –Part 12: Sample preparation and reference materials | ||
| U.S. Food and Drug Administration Good Laboratory Practice(GLP) 21 CFR Part 58 | ||
| IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6:General requirements for basic safety and essentialperformance - Collateral standard: Usability | Usability | |
| IEC 62366-1:2015 Medical devices - Part 1: Application ofusability engineering to medical devices | Pass | |
| FDA Guidance FDA-2011-D-0469 - Applying Human Factorsand Usability Engineering to Medical Devices, Guidance forIndustry and Food and Drug Administration Staff - February 3,2016 | ||
| FDA Guidance FDA-2013-D-0616 - Content of PremarketSubmissions for Management of Cybersecurity in MedicalDevices, Guidance for Industry and Food and DrugAdministration Staff - October 2, 2014 | CybersecurityCompliance | Pass |
| ISO 14971:2019 - Medical devices - Application of riskmanagement to medical devicesFDA 21 CFR 820 | Risk Management | Pass |
| Federal Communications Commission, Part 15 Low PowerCommunication Device Transmitter | Bluetooth SIGCompliance | |
| IEEE/ANSI C63.27:2017 Evaluation of Wireless Coexistence | Pass | |
| AAMI TIR 69:2020 Risk Management of Radio-FrequencyWireless Coexistence for Medical Devices and Systems | ||
| ANSI C63.19:2011 - Methods of Measurement ofCompatibility Between Wireless Communication Devices andHearing Aids | Radio FrequencyImmunity | Pass |
| ANSI ASA S3.22:2014 – Specification of Hearing AidCharacteristics | ElectroacousticPerformance | |
| ANSI CTA 2051:2017 – Personal Sound AmplificationPerformance Criteria | Pass | |
| IEC 60118-7:2005 |
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Image /page/26/Picture/0 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, dark blue 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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NOTE: Full Non-Clinical Performance Testing results, including acceptance criteria and testing performed to internal specifications, are reported in the 510(k) submission.
ANSI ASA S3.22:2014 Measurements:
In order to demonstrate substantial equivalence with the predicate device, the MDHearing Smart Hearing Aid was evaluated per ANSI ASA S3.22 for acoustic performance. The results are summarized below.
| Test SpecificationApplicable Standard(Clause) | Predicate Device:Bose Hearing Aid(DEN180026)* | Subject Device:MDHearing SmartHearing Aid | Discussion |
|---|---|---|---|
| OSPL90 curveANSI S3.22:2014(6.2) | Image: graph of frequency vs dB SPL | See Figure 7 | Comparable topredicate andsuitable for theintended user. Testmethod and hearingaid characteristicboth in accordancewith ANSIS3.22:2014. |
| MAX OSPL90ANSI S3.22:2014(6.2) | 115 dB SPL, which isless than or equal to120 dB SPL | Less than or equal to120 dB SPL | Comparable to thepredicate andsuitable for theintended user.Both inconformity toANSI/CTA-2051. |
| HFA-OSPL90ANSI S3.22:2014(6.3) | 112 dB SPL | 109 dB SPL | Both adequate forfitting up tomoderate hearingloss (55 dB HL) asprescribed by NAL-NL2. Clinicalvalidation study datasupport substantialequivalence. |
| HFA FOGANSI S3.22:2014(6.5) | 43 dB | 35 dB SPL | Both adequate forfitting up tomoderate hearingloss (55 dB HL) asprescribed by NAL-NL2. Clinicalvalidation study data |
| Test SpecificationApplicable Standard(Clause) | Predicate Device:Bose Hearing Aid(DEN180026)* | Subject Device:MDHearing SmartHearing Aid | Discussion |
| RTGANSI S3.22:2014(6.7) | 36 dB | 35 dB | support substantialequivalence. |
| FrequencyresponseANSI S3.22:2014(6.8) | Image: Frequency response plot | See Figure 7 | Comparable topredicate andsuitable for theintended user. Testmethod and hearingaid characteristicboth in accordancewith ANSI S3.22. |
| FrequencyresponsebandwidthANSI/CTA 2051:2017(4.1) with underlyingtest method ANSIS3.22:2014 (6.9) | <200 Hz to >8000 Hz | 200 Hz to 7000 Hz | Comparable to thepredicate andsuitable for theintended user.Both inconformity toANSI/CTA-2051. |
| Harmonic DistortionANSI S3.22:2014(6.11) | 3.6% | 500 Hz 3%800 Hz 1%1600 Hz 0%THD ≤ 5% | Both inconformity toANSI/CTA-2051. |
| EINANSI S3.22:2014(6.12) | 26 dB SPL | 24 dB SPL | Both inconformity toANSI/CTA-2051. |
| Battery CurrentANSI S3.22:2014(6.13) | N/A | 1.2 mA | Predicate device wasrechargeable. |
| Estimated Battery | N/A** | Under normal | |
| Test SpecificationApplicable Standard(Clause) | Predicate Device:Bose Hearing Aid(DEN180026)* | Subject Device:MDHearing SmartHearing Aid | Discussion |
| LifeANSI/CTA 2051:2017(4.7) | operating conditionsthe size 312 batterylasts around 100hours prior toreplacement. | In conformity toANSI/CTA-2051. | |
| LatencyANSI/CTA 2051:2017(4.8) | ≤ 15ms** | ≤ 15ms | Both inconformity toANSI/CTA-2051. |
| Reporting ofHearing AidFeaturesANSI/CTA 2051:2017(4.10-4.17) | N/A** | -Fixed or LevelDependentFrequencyEqualization-Level Dependent-Gain/Compression-SNR Enhancement-Noise Reduction-Feedback Control/Cancellation-Personalization-Device Coupling tothe Ear-WirelessConnectivity | In conformity toANSI/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).
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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.
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- 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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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.
§ 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.