The Nuance Audio Hearing Aid Software is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The software utilizes a preset fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.

Device Description

The Nuance Audio Hearing Aid Software is a software-only device that is comprised of a pair of software modules which operate on two separate required products: (1) Nuance Audio Application on a compatible iOS or Android product, and (2) Nuance Audio Hearing Aid Software Firmware (FW) using the compatible wearable electronic computing platform, the Nuance Audio Glasses (smart glasses). The Nuance Audio Hearing Aid Software amplifies sounds for adult users, 18 years of age and older, who have a perceived mild to moderate hearing loss. The Nuance Audio™ App, iOS or Android mobile application, quides the user through the initial onboarding and set up process providing step-by-step instructions to guide the users can select from four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied. The user may also adjust the overall volume, noise reduction, and microphone directionality. The device incorporates a feedback control algorithm to reduce the likelihood of the user experiencing acoustic feedback. The same amplification settings will be applied to both the left and right ear. This device can be fitted by a user without assistance from a hearing healthcare professional.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nuance Audio Hearing Aid Software, based on the provided text:

Nuance Audio Hearing Aid Software: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric/Standard	Acceptance Criteria (Target)	Reported Device Performance (Nuance Audio Hearing Aid Software)
Electro-Acoustics	Latency Clause	Meets 21 CFR 800.30 requirements (implicit: similar to predicate or within acceptable tolerance)	8.8 ms (Predicate: 3.15 ms – performance testing evaluated differences and supports substantial equivalence)
	Frequency Response	Meets 21 CFR 800.30 requirements (implicit: similar to predicate or within acceptable tolerance)	200Hz - 6300 Hz (Predicate: 100 — 10,000 Hz – performance testing evaluated differences and supports substantial equivalence)
	Self-Generated Noise	Meets 21 CFR 800.30 requirements (implicit: similar to predicate or within acceptable tolerance)	29.9 dBA (Predicate: 28 dBA – performance testing evaluated differences and supports substantial equivalence)
	Harmonic Distortion	Less than or equal to 1%	Less than or equal to 1%
	Maximum Output Value	Meets 21 CFR 800.30 requirements (implicit: similar to predicate or within acceptable tolerance)	112.7 dB SPL (Predicate: 106 dB SPL – performance testing evaluated differences and supports substantial equivalence)
	Insertion Gain	Within 5 dB of predicate device at most frequencies; within 5 dB of NAL-NL2 targets except at one frequency (5 kHz, within 8 dB).	Within 5 dB of predicate device at most frequencies; within 5 dB of NAL-NL2 targets except at one frequency (5 kHz, within 8 dB).
Usability Testing	Critical Errors	Zero critical errors during simulated use scenarios	All tasks completed without critical errors.
	User Satisfaction	Overall positive satisfaction on usability	Overall positive satisfaction on the usability of the device expressed by users.
	Acceptance Criteria	All defined acceptance criteria for EN 62366-1:2015 met	All defined acceptance criteria were met (EN 62366-1:2015).
Clinical Performance	Real-Ear Aided Response (REAR)	Each preset (A, B, C, D) within ±6 dB of NAL-NL2 targets at 250, 500, 1000, 2000, and 4000Hz.	Each Nuance Audio Hearing Aid Software preset (A, B, C, and D) profile was within the pre-specified criterion range of NAL-NL2 targets (±6 dB).
	Speech-in-Noise (SNR-50)	Improvement in SNR (threshold not explicitly stated, but typically a positive improvement is expected)	Average unaided vs. aided improvement was 3.49 dB.
	IOI-HA Total Score	Clinically meaningful outcome score for the intended population (threshold not explicitly stated)	Mean IOI-HA total score was 29.04 (SD = 4.62), considered clinically meaningful for individuals with perceived mild to moderate hearing loss to achieve hearing benefit.
General Compliance	Special Controls	Meets special controls for 874.3335 (including addressing clinical performance for fitting strategy)	Meets special controls for 874.3335, and clinical data provided to address differences in technology (preset vs. self-fitting) to support substantial equivalence.
	OTC Hearing Aids	Meets specifications associated with over-the-counter hearing aids (21 CFR 800.30)	Nuance Audio Hearing Aid Software was shown to meet the specifications associated with over-the-counter hearing aids (21 CFR 800.30).

2. Sample Size Used for the Test Set and Data Provenance

Usability Testing:
- Sample Size: 15 representative adult users.
- Data Provenance: Not explicitly stated, but implies prospective data collection from participants in a usability validation study.
Real-ear measurements:
- Sample Size: 29 participant ears.
- Data Provenance: Not explicitly stated, but implies prospective data collection from participants.
Speech in noise clinical performance:
- Sample Size: 19 adults with mild to moderate hearing loss.
- Data Provenance: Not explicitly stated, but implies prospective data collection from participants.
Patient Reported Outcome Measure (IOI-HA):
- Sample Size: 23 adult subjects identified with self-perceived mild-to-moderate sensorineural hearing loss.
- Data Provenance: Not explicitly stated, but implies prospective data collection after a 14-day trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly mention the use of experts to establish ground truth for the test set from these clinical studies. Instead, the studies compare the device's performance against:

Objective measures: NAL-NL2 targets (a commonly used clinical fitting formula).
Standardized clinical outcomes: SNR-50 (speech-in-noise ratio) and IOI-HA scores (patient-reported outcome).
Usability standards: IEC 62366-1:2015.

The ground truth for the "typical mild to moderate hearing loss configurations" used to generate the presets (Urbanski et al., 2021) suggests a reliance on established audiological research rather than individual expert consensus for a specific test set.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned for any of the test sets. The studies appear to rely on direct measurements, standardized clinical tests, or user feedback.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is reported in relation to human readers improving with AI vs. without AI assistance. The device is a "hearing aid software" rather than an interpretative AI for medical imaging, for example, where MRMC studies are common. The clinical performance studies directly evaluate the device's efficacy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described for "Performance Testing" (Electro-Acoustics, Real-ear measurements, Speech in Noise, IOI-HA) represent standalone performance of the algorithm integrated into the compatible hardware (Nuance Audio Glasses) without human-in-the-loop clinical decision-making. The usability testing assesses the user's ability to operate the device effectively, which is human-in-the-loop operation, but the core performance metrics are evaluating the device's output.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test sets consisted of:

Objective Audiological Targets: NAL-NL2 (National Acoustics Laboratories-Non-Linear 2) fitting formula.
Standardized Clinical Metrics: SNR-50 (signal-to-noise ratio at 50% word recognition) and International Outcome Inventory for Hearing Aids (IOI-HA) scores.
Usability Standards: Compliance with IEC 62366:2015 and completion of tasks without critical errors.
Bench Test Standards: Adherence to ISO, ANSI/ASA, CTA, IEC standards for biocompatibility, electrical safety, EMC, battery safety, and software.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. The device uses "four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied." This suggests that the "training" or development of these presets was based on established audiological research and fitting formulas, rather than a data-driven machine learning training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the "training" (i.e., the generation of the preset fitting strategies) for the Nuance Audio Hearing Aid Software was established based on:

Published Audiological Research: "Typical mild to moderate hearing loss configurations (Urbanski et al., 2021)."
Standardized Fitting Formula: Application of the NAL-NL2 (National Acoustics Laboratories-Non-Linear 2) gain settings to these configurations.

This indicates that the presets are derived from established audiological science and validated hearing loss profiles, rather than being "learned" from a distinct training dataset with a separate ground truth determination process.

Summary

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January 31, 2025

Luxottica Group S.P.A. John Luna Executive Advisor Piazzale Cadorna 3 Milan, 20123 Italy

Re: K243150

Trade/Device Name: Nuance Audio Hearing Aid Software Regulation Number: 21 CFR 874.3335 Regulation Name: Air Conduction Hearing Aid Software Regulatory Class: Class II Product Code: SCR Dated: September 27, 2024 Received: September 30, 2024

Dear John Luna:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

SRINIVAS NANDKUMAR -S

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243150

Device Name

Nuance Audio Hearing Aid Software

Indications for Use (Describe)

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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Nuance Audio Hearing Aid Software

510(k) Summary

1. DEVICE [PER 807.92(a)(2)]

Name of Device: Nuance Audio Hearing Aid Software Classification Name: Air Conduction Hearing Aid Software Common Name: Hearing Aid Software Regulation: 21 CFR §874.3335 Regulatory Class: II Product Code: SCR

2. PREDICATE DEVICE [PER 807.92(a)(3)]

Predicate: Apple Hearing Aid Feature (HAF) DEN230081 This predicate has not been subject to a design-related recall.

3. DEVICE DESCRIPTION [PER 807.92(a)(4)]

Image /page/4/Picture/8 description: The image shows a pair of glasses and a smartphone screen. The glasses are black and have a rectangular frame. The smartphone screen displays an app interface with various settings and options, including battery level at 80%, noise tracking, background noise level, preset audio settings, and audio mode set to "All-around". The app also has a navigation bar at the bottom with icons for different sections.

Imaqe 1

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The Nuance Audio Hearing Aid Software amplifies sounds for adult users, 18 years of age and older, who have a perceived mild to moderate hearing loss. The Nuance Audio™ App, iOS or Android mobile application, quides the user through the initial onboarding and set up process providing step-by-step instructions to guide the users can select from four preset options, which are generated from typical mild to moderate hearing loss configurations (Urbanski et al., 2021) with NAL-NL2 gain settings applied. These audiogram hearing loss profiles have been validated as being appropriate for individuals with mild to moderate hearing loss. Therefore, this provides support for their use in deriving the presets for this device for the intended user population of individuals with perceived mild to moderate hearing loss. Note that the output of an individual user's hearing test is not used in the fitting of this device.

The different preset listening profiles are represented as Preset A, B, C, and D, respectively, as shown in the software interface below (Image 2; Nuance Audio Hearing Aid Software). The user may also adjust the overall volume, noise reduction, and microphone directionality. The device incorporates a feedback control algorithm to reduce the likelihood of the user experiencing acoustic feedback. The same amplification settings will be applied to both the left and right ear. This device can be fitted by a user without assistance from a hearing healthcare professional.

NOTE: Nuance Audio Glasses refers to the compatible hardware platform together with the hearing aid functionality enabled software.

Image /page/5/Picture/3 description: The image shows a mobile phone screen displaying an application interface. At the top, the battery level is indicated as 80%, along with a 'Noise tracking' feature. Below, the 'Background noise' is set to 'Low'. A 'Preset' section allows users to select between options 'A', 'B', 'C', and 'D', with 'D' currently selected. At the bottom, the 'Audio mode' is set to 'All-around'.

Image 2: Nuance Audio™ App Main Screen for iOS and Android

4. INTENDED USE

The Nuance Audio Hearing Aid is a software-only mobile medical application that is intended to be used with a compatible wearable electronic computing platform. The Nuance Audio Hearing Aid Software is intended to amplify sounds for individuals 18 years of age or older with perceived mild to moderate hearing loss. The Nuance Audio Hearing Aid Software also allows for user customization to suit their perceived hearing needs through utilizing 4 pre-set fitting options based

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on typical hearing loss profiles of a mild to moderate hearing loss (Urbanski et al, 2021). The presets are selected subjectively by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The Nuance Audio Hearing Aid Software device is intended for over-the-counter (OTC) use.

5. INDICATIONS FOR USE

The Nuance Audio Hearing Aid Software is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing loss. The software utilizes a preset fitting options and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for overthe-counter (OTC) use.

6. Comparison of Intended Use and Technological Characteristics with the Predicate

A comparison of the intended use and technological characteristics, e.g., features, parameter settings etc. of the subject device to the predicate (see Table 1) begins with the intended use and then summarizes the technological characteristics of the Nuance Audio Hearing Aid Software in comparison to the predicate, the Apple Hearing Aid Feature (HAF). Both are software devices that are intended to amplify sound for individuals 18 and older with perceived mild to moderate hearing loss. The form factor and fitting strategies have differences and the description of the similarities and the strategies employed to address those differences is explained below in Section 8.

	Subject Device	Predicate Device	Discussion
Device TradeName	Nuance Audio HearingAid Software	Hearing Aid Feature(HAF)
FDA Number	K243150	DEN230081
Product code	SCR	SCR	Same as predicate
RegulationNumber	21 CFR 874.3335	21 CFR 874.3335	Same as predicate
Regulationname	Air-Conduction HearingAid Software	Air-Conduction HearingAid Software	Same as predicate
Indications forUse	The Nuance Audio HearingAid Software is a software-only mobile medicalapplication that is intendedto be used with compatiblewearable electronicproducts. The feature isintended to amplify soundfor individuals 18 years ofage or older with perceivedmild to moderate hearingloss. The software utilizes apreset fitting strategy and is	The Hearing Aid Feature isa software-only mobilemedical application that isintended to be used withcompatible wearableelectronic products. Thefeature is intended toamplify sound for individuals18 years of age or olderwith perceived mild tomoderate hearingimpairment. The HearingAid Feature utilizes a self-	Both devices have thesame intended use for thesame target population(adults with a perceivedmild to moderate hearingloss). Both devices can befitted by a user without theassistance of a hearinghealthcare professional.

Table 1.

Summary of Substantial Equivalence

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adjusted by the user tomeet their hearing needswithout the assistance of ahearing healthcareprofessional. The device isintended for over-the-counter use.	fitting strategy and isadjusted by the user tomeet their hearing needswithout the assistance of ahearing healthcareprofessional. The device isintended for Over-the-Counter use.
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	Subject Device	Predicate	Discussion
Device TradeName	Nuance AudioHearing Aid Software	Hearing Aid Feature(HAF)
WearablePlatform	The Nuance Audio HearingAid Software is housed inthe frames of a commercialpair of smart glasses, theNuance Audio Glasses. Themicrophones and speakersare in the frames' templepieces, with the speakersdirecting the amplifiedsound to the ear canalproviding the user with anopen ear canal listeningexperience. Nuance AudioGlasses refers to thecompatible hardwareplatform together with thehearing aid functionalityenabled software.	The HAF software is housedin the Apple AirPods Pro 2,a consumer electronicearbud. The amplified soundis delivered via an ear-tipsituated inside the ear canal.	Differences in wearableand firmware platform.The Nuance AudioGlasses deliver the air-conducted signal withoutthe device obstructing theear canal, whereas thepredicate device uses acompatible hardware thatresides within the conchaand ear canal.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.Clinical performance dataof the subject device ispresented in Section 8,Statement of SubstantialEquivalence.
Fitting method	The Nuance Audio App, iOSor Android mobileapplication, guides the userthrough the initialonboarding and set upprocess providing step-by-step instructions to guidethe users. The users canselect from four presetoptions, which aregenerated from typical mildto moderate hearing lossconfigurations (Urbanski etal., 2021) with NAL-NL2gain settings applied. Theseamplification profiles havebeen validated as beingappropriate for individualswith mild to moderatehearing loss. Note that theoutput of an individualuser's hearing test is notused in the fitting of thisdevice. The different presetamplification profiles arerepresented as Preset A, B,C, and D, respectively.The user may also adjust theoverall loudness, noisereduction, and microphonedirectionality using theNuance Audio App.Additionally, the user canaccess volume adjustmentsvia the multifunction buttonon the Nuance AudioGlasses. The sameamplification settings will beapplied the for the left andright ear. This device can befitted by a user withoutassistance from a hearinghealthcare professional.	The Apple HAF requires theuser to select a hearing testresult from the Health app onthe iOS device. Once theHAF onboarding iscompleted, then fine-tuningbecomes available to theuser.There are three types ofadjustments (Amplification,Tone and Balance) that theuser can make to optimizetheir hearing preferences.Descriptions of the threefine-tuning:sliders can be found below:1. Amplification - Makes thesounds louder or quieter2. Tone - Changes theamount of high and low pitchsounds (e.g. modify the'brightness' of the sound).3. Balance - Adjusts the ratioof sound level between theleft and right AirPods Pro 2earbuds.The user is able to adjustthe fine-tuning settingsanytime on a compatibleiPhone, iPad, MacBook orApple Watch.	The subject deviceincorporates a presetfitting method while thepredicate uses a self-fitting strategy. Both thesubject and predicatedevice meet theamplification needs fortheir intended users.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence,including 800.30(e).Clinical performance dataof the subject device ispresented in Section 8,Statement of SubstantialEquivalence.
Input Signalcompression	Wide dynamic rangecompression	Wide dynamic rangecompression	Similar to predicate
Microphones	Microphones are in thetemples of the NuanceAudio Glasses'. During use,can be configured by theuser in omnidirectional (all-around) or directional(frontal) modes.	Dual beamformingmicrophones and an inwardfacing microphone.	Similar to predicate.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence,including 800.30(e).
BatteryTechnology	Rechargeable lithium-ionbattery	Rechargeable lithium-ionbattery	Same as predicate
Battery Lifetime	Battery life of ~6 hrs. perbattery single charge forhearing aid use.	Battery life of ~6 hrs. perbattery single charge forhearing aid feature	Same as predicate
Active NoiseReduction	Present	Present	Similar to Predicate
Mobile App	Mobile application on acompatible iOS or Androidoperating platform.	Mobile application on acompatible iOS operatingplatform.	Similar to Predicate
Remotefirmwareupdates	The subject device allowsfor remote firmwareupdates.	The predicate allows forremote firmware updates.	Same as Predicate

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Electro-AcousticCharacteristics	Subject Device	Predicate	Discussion
	Nuance Audio HearingAid Software	Hearing Aid Feature(HAF)
Latency Clause	8.8 ms	3.15 ms	The subject meets 21CFR800.30 requirements.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.
FrequencyResponse	200Hz - 6300 Hz	100 — 10,000 Hz	The subject meets 21CFR800.30 requirements.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.

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Self-GeneratedNoise Value	29.9 dBA	28 dBA	The subject meets 21CFR800.30 requirements.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.
HarmonicDistortion	Less than or equal to 1%	Less than or equal to 1%	The subject meets 21CFR800.30 requirements.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.
MaximumOutput Value(Output SoundPressure Level90) (OSPL90)	112.7 dB SPL	106 dB SPL	The subject meets 21CFR800.30 requirements.Performance testingevaluated thesedifferences in technologyand the results supportsubstantial equivalence.

7. Performance Testing

Both the subject and predicate devices were tested for conformity to the following FDA recognized consensus standards applicable to OTC hearing aids for their intended use.

Biocompatibility

ISO 10993-1 Biological evaluation of medical devices ●
ISO 10993-5 Biological evaluation of medical devices ●
ISO 10993-10 Biological evaluation of medical devices ●
ISO 10993-12 Biological evaluation of medical devices ●

Electro-Acoustics

ANSI/ASA S3.22 2014 Measurements ●
CTA 2051:2017

Electrical Safety, EMC, Battery Safety, Software and Labeling

IEC 60601-1; 2005 + AMDI:2012; + AMD2: 2021 ●
IEC 60601-1-2; 2014, AMDI:2020; Part 1-2 ●
. IEC 60601-2-66: 2019
ISO 15223-1:2021 4th edition ●
IEC 62304:2006; 1st Edition +A1:2016 ●

Consistent with the predicate, the Nuance Audio Hearing Aid Software passed all relevant nonclinical performance testing and biological endpoints with the representative, compatible computing platform hardware (smart glasses) being verified that the amplified acoustic signal output by the hardware platform is calibrated.

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Similarly, software verification and validation, bench performance testing against established consensus standards for electrical safety, EMC and battery safety were conducted with the representative, compatible hardware (smart glasses) to verify the amplified acoustic signal output by the hardware platform.

Confirmatory bench testing to insertion gain was conducted to help support substantial equivalence of the subject device to the predicate. Insertion gain using an International Speech Test Signal (ISTS) was measured at 65 dB SPL from 250Hz to 5000Hz for both the Nuance Audio Glasses and the Apple AirPods Pro 2 devices (side-by-side testing) using a head and torso simulator (HATS). Both the subject and predicate devices were fit using the audiometric thresholds from Hearing Loss Profile 3 from Urbanski et al. (2021). This hearing profile is a sloping mild to moderate hearing loss (Urbanski et al, 2021; Hearing Loss Profile 3). This corresponds to Preset C for the Nuance Audio Hearing Aid Software. The subject device insertion qains were within 5 dB of the predicate device at most frequencies under these test conditions. In addition to the comparative testing, the subject device insertion gains were within 5 dB of the NAL-NL2 targets except at one frequency (5 kHz. within 8 dB).

Usability Testing

Per Special Control 3 and as an OTC medical device intended to be used without the support of a hearing healthcare professional, the Nuance Audio Hearing Aid Software was assessed in compliance with IEC 62366:2015 to complete human factors/usability validation. The 15 representative adult users in the study participated in key use scenarios that included critical and essential tasks that were necessary to provide the appropriate context of use. They were all novice users of hearing technology and were of varying ages (24 - 58 yrs.).

The specific objectives of this human factors engineering / usability engineering validation test were as follows:

. Demonstrate that the device and its associated components/accessories can be used successfully in simulated use scenarios by utilizing manufacturer provided identification of intended users and use environments, indications and contraindications for use, multiple media instructional information to effectively and safely operate the device in different use environments; and
. ensure that the use-related safety issues associated with the Nuance Audio Glasses have been adequately mitigated.

The 15 representative users were able to complete all tasks without critical errors and expressed an overall positive satisfaction on the usability of the device. All defined acceptance criteria were met (EN 62366-1:2015).

8. Statement of Substantial Equivalence

The Nuance Audio Hearing Aid Software has the same intended use and indications for use compared to the predicate, Hearing Aid Feature (HAF) with differences in the technological characteristics and principles of operation. These differences do not raise different questions of safety and effectiveness than those of the predicate device. However, performance data was provided to address these differences in technology and support substantial equivalence to the predicate.

The Nuance Audio Hearing Aid Software is housed in the frames of a commercial pair of smart glasses,

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the Nuance Audio Glasses. The microphones and speakers are in the frames' temple pieces, with the speakers directing the amplified sound to the ear canal providing the user with an open ear canal listening experience. Nuance Audio Glasses refers to the compatible hardware platform together with the hearing aid functionality enabled software. The predicate device uses a compatible hardware that resides within the concha and ear canal. Specifically, the HAF software is housed in the Apple AirPods Pro 2, and the amplified sound is delivered via an ear-tip situated inside the ear canal. The Nuance Audio Glasses are a novel way to provide amplification for those users with a perceived mild to moderate hearing loss who don't wish to wear a device in their ear canal. The subject device has met the same Technical Specifications and electro-acoustic requirements as the predicate device, and any difference due to the subject device wearable platform (i.e., Nuance Audio Glasses) have been verified by clinical and non-clinical performance measurements.

The Nuance Audio Hearing Aid Software is different in fitting method to the predicate device in that the subject device provides the user clinically validated preset options using four pre- determined audiogram profile presets (Urbanski et al, 2021), whereas the HAF utilizes a self-fitting strategy with audiogram input. While the methodologies are different operationally, the end user still has the ability to acquire and use an OTC hearing aid that can be fit without professional healthcare assistance. The Nuance Audio Hearing Aid Software was shown to meet the specifications associated with over-the-counter hearing aids (21 CFR 800.30).

The Nuance Audio Hearing Aid Software also meets the special controls for 874.3335. Special control number 1 under 874.3335 requires clinical performance data to validate a hearing aid software's selffitting strategy. In this case, the Nuance Audio Hearing Aid Software does not have a self-fitting strategy, as it uses preset programs to fit the user. However, additional performance data (including clinical data) was provided to evaluate the differences in technology (preset vs. self-fitting) in evidence to support that the subject device and predicate were substantially equivalent.

. Real-ear measurements were assessed using subject device and compared to a commonly used clinical fitting formula (NAL-NL2). The real-ear aided response (REAR) of 29 participant ears was compared to NAL-NL2 targets at 250, 500, 1000, 2000, and 4000Hz. The results showed that each Nuance Audio Hearing Aid Software preset (A, B, C, and D) profile was within the pre-specified criterion range of NAL-NL2 targets (±6 dB).
. Speech in noise clinical performance of the Nuance Audio Hearing Aid Software using Nuance Audio Glasses was conducted with 19 adults with mild to moderate hearing loss to determine the signal-to-noise ratio at which the user can recognize and repeat 50% of the words (SNR-50). Results of the speech-in-noise testing demonstrated the average unaided vs. aided improvement was 3.49 dB.
. A patient reported outcome measure, the International Outcome Inventory for Hearing Aids (IOI-HA; Cox, 2002) was conducted on 23 adult subjects after a 14-day trial with the Nuance Audio Glasses. The subjects were identified as having self-perceived mild-to-moderate sensorineural hearing loss. The mean IOI-HA total score was 29.04 (SD = 4.62). This outcome score is considered to be clinically meaningful for the intended population, such that individuals with perceived mild to moderate hearing loss may achieve hearing benefit from using this device.

The difference in preset vs. self-fitting strategy between the subject and predicate devices do not introduce different questions of safety and effectiveness, as both devices meet the amplification needs for the target population with perceived mild to moderate hearing loss. The Nuance Audio Hearing Aid Software is substantially equivalent in intended use with differences in technological characteristics to the predicate device, Hearing Aid Feature (DEN230081).

Regulation Number and Section

N/A