(123 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device's functionality based on preset options, user adjustments, and a feedback control algorithm, without mentioning any AI/ML components.
Yes
The device is intended to amplify sound for individuals with hearing impairment, which classifies it as a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an amplifier for individuals with perceived hearing impairment, not a tool to diagnose or identify a medical condition. Its purpose is to augment hearing, not to assess hearing loss.
No
While the device is described as "software-only," it explicitly states it operates on a "compatible wearable electronic computing platform, the Nuance Audio Glasses (smart glasses)," which is a hardware component. The software is comprised of modules operating on both a mobile device and the smart glasses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Nuance Audio Hearing Aid Software is designed to amplify sound for individuals with perceived hearing impairment. It works by processing external sounds and delivering them to the user's ear.
- Lack of Sample Analysis: The device does not involve the collection or analysis of any biological samples from the user. Its function is based on processing auditory input and providing amplified output.
Therefore, the Nuance Audio Hearing Aid Software falls under the category of a hearing aid or a similar type of medical device that addresses a physical function (hearing) rather than performing diagnostic tests on biological samples.
N/A
Intended Use / 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 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.
Product codes
SCR
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. These audiogram hearing loss profiles have been validated as being appropriate for individuals with 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
User without the assistance of a hearing healthcare professional / Over-the-Counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Confirmatory bench testing to insertion gain was conducted. 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 corresponds to Preset C for the Nuance Audio Hearing Aid Software.
Usability testing was conducted with 15 representative adult users. Participants were novice users of hearing technology of varying ages (24 - 58 yrs.).
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.
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).
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Confirmatory bench testing to insertion gain.
Sample size: Not applicable (measurements on devices using HATS).
Key results: The subject device insertion gains were within 5 dB of the predicate device at most frequencies under these test conditions. In addition, 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:
Human Factors/Usability validation per IEC 62366:2015.
Sample size: 15 representative adult users.
Key results: 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.
Real-ear measurements:
Clinical performance data.
Sample size: 29 participant ears.
Key results: 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:
Clinical performance data.
Sample size: 19 adults.
Key results: The average unaided vs. aided improvement was 3.49 dB.
Patient Reported Outcome Measure (IOI-HA):
Clinical performance data.
Sample size: 23 adult subjects.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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.
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Nuance Audio Hearing Aid Software
Indications for Use (Describe)
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.
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)]
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). See image 1.
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
5
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
6
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 Trade | |||
| Name | Nuance Audio Hearing | ||
| Aid Software | Hearing Aid Feature | ||
| (HAF) | |||
| FDA Number | K243150 | DEN230081 | |
| Product code | SCR | SCR | Same as predicate |
| Regulation | |||
| Number | 21 CFR 874.3335 | 21 CFR 874.3335 | Same as predicate |
| Regulation | |||
| name | Air-Conduction Hearing | ||
| Aid Software | Air-Conduction Hearing | ||
| Aid Software | Same as predicate | ||
| 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 strategy and is | The Hearing Aid Feature 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 Hearing | |||
| Aid Feature utilizes a self- | Both devices have the | ||
| same intended use for the | |||
| same target population | |||
| (adults with a perceived | |||
| mild to moderate hearing | |||
| loss). Both devices can be | |||
| fitted by a user without the | |||
| assistance of a hearing | |||
| healthcare professional. |
Table 1.
Summary of Substantial Equivalence
7
| 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. | 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. | |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
| Subject Device | Predicate | Discussion | |
|---|---|---|---|
| Device Trade | |||
| Name | Nuance Audio | ||
| Hearing Aid Software | Hearing Aid Feature | ||
| (HAF) | |||
| Wearable | |||
| Platform | The Nuance Audio Hearing | ||
| Aid Software is housed in | |||
| the frames of a commercial | |||
| pair of smart glasses, 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 HAF software is housed | ||
| in the Apple AirPods Pro 2, | |||
| a consumer electronic | |||
| earbud. The amplified sound | |||
| is delivered via an ear-tip | |||
| situated inside the ear canal. | Differences in wearable | ||
| and firmware platform. | |||
| The Nuance Audio | |||
| Glasses deliver the air- | |||
| conducted signal without | |||
| the device obstructing the | |||
| ear canal, whereas the | |||
| predicate device uses a | |||
| compatible hardware that | |||
| resides within the concha | |||
| and ear canal. | |||
| Performance testing | |||
| evaluated these | |||
| differences in technology | |||
| and the results support | |||
| substantial equivalence. | |||
| Clinical performance data | |||
| of the subject device is | |||
| presented in Section 8, | |||
| Statement of Substantial | |||
| Equivalence. | |||
| Fitting method | The Nuance Audio App, iOS | ||
| or Android mobile | |||
| application, guides the user | |||
| through the initial | |||
| onboarding and set up | |||
| process providing step-by- | |||
| step instructions to guide | |||
| the users. 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 | |||
| amplification profiles have | |||
| been validated as being | |||
| appropriate for individuals | |||
| with 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 | |||
| amplification profiles are | |||
| represented as Preset A, B, | |||
| C, and D, respectively. | |||
| The user may also adjust the | |||
| overall loudness, noise | |||
| reduction, and microphone | |||
| directionality using the | |||
| Nuance Audio App. | |||
| Additionally, the user can | |||
| access volume adjustments | |||
| via the multifunction button | |||
| on the Nuance Audio | |||
| Glasses. The same | |||
| amplification settings will be | |||
| applied the for the left and | |||
| right ear. This device can be | |||
| fitted by a user without | |||
| assistance from a hearing | |||
| healthcare professional. | The Apple HAF requires the | ||
| user to select a hearing test | |||
| result from the Health app on | |||
| the iOS device. Once the | |||
| HAF onboarding is | |||
| completed, then fine-tuning | |||
| becomes available to the | |||
| user. | |||
| There are three types of | |||
| adjustments (Amplification, | |||
| Tone and Balance) that the | |||
| user can make to optimize | |||
| their hearing preferences. | |||
| Descriptions of the three | |||
| fine-tuning: | |||
| sliders can be found below: |
- Amplification - Makes the
sounds louder or quieter - Tone - Changes the
amount of high and low pitch
sounds (e.g. modify the
'brightness' of the sound). - Balance - Adjusts the ratio
of sound level between the
left and right AirPods Pro 2
earbuds.
The user is able to adjust
the fine-tuning settings
anytime on a compatible
iPhone, iPad, MacBook or
Apple Watch. | The subject device
incorporates a preset
fitting method while the
predicate uses a self-
fitting strategy. Both the
subject and predicate
device meet the
amplification needs for
their intended users.
Performance testing
evaluated these
differences in technology
and the results support
substantial equivalence,
including 800.30(e).
Clinical performance data
of the subject device is
presented in Section 8,
Statement of Substantial
Equivalence. |
| Input Signal
compression | Wide dynamic range
compression | Wide dynamic range
compression | Similar to predicate |
| Microphones | Microphones are in the
temples of the Nuance
Audio Glasses'. During use,
can be configured by the
user in omnidirectional (all-
around) or directional
(frontal) modes. | Dual beamforming
microphones and an inward
facing microphone. | Similar to predicate.
Performance testing
evaluated these
differences in technology
and the results support
substantial equivalence,
including 800.30(e). |
| Battery
Technology | Rechargeable lithium-ion
battery | Rechargeable lithium-ion
battery | Same as predicate |
| Battery Lifetime | Battery life of ~6 hrs. per
battery single charge for
hearing aid use. | Battery life of ~6 hrs. per
battery single charge for
hearing aid feature | Same as predicate |
| Active Noise
Reduction | Present | Present | Similar to Predicate |
| Mobile App | Mobile application on a
compatible iOS or Android
operating platform. | Mobile application on a
compatible iOS operating
platform. | Similar to Predicate |
| Remote
firmware
updates | The subject device allows
for remote firmware
updates. | The predicate allows for
remote firmware updates. | Same as Predicate |
8
9
| Electro-Acoustic
| Characteristics | Subject Device | Predicate | Discussion |
|---|---|---|---|
| Nuance Audio Hearing | |||
| Aid Software | Hearing Aid Feature | ||
| (HAF) | |||
| Latency Clause | 8.8 ms | 3.15 ms | The subject meets 21CFR |
| 800.30 requirements. | |||
| Performance testing | |||
| evaluated these | |||
| differences in technology | |||
| and the results support | |||
| substantial equivalence. | |||
| Frequency | |||
| Response | 200Hz - 6300 Hz | 100 — 10,000 Hz | The subject meets 21CFR |
| 800.30 requirements. | |||
| Performance testing | |||
| evaluated these | |||
| differences in technology | |||
| and the results support | |||
| substantial equivalence. |
10
| Self-Generated
Noise Value | 29.9 dBA | 28 dBA | The subject meets 21CFR
800.30 requirements.
Performance testing
evaluated these
differences in technology
and the results support
substantial equivalence. |
|----------------------------------------------------------------------------|--------------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Harmonic
Distortion | Less than or equal to 1% | Less than or equal to 1% | The subject meets 21CFR
800.30 requirements.
Performance testing
evaluated these
differences in technology
and the results support
substantial equivalence. |
| Maximum
Output Value
(Output Sound
Pressure Level
90) (OSPL90) | 112.7 dB SPL | 106 dB SPL | The subject meets 21CFR
800.30 requirements.
Performance testing
evaluated these
differences in technology
and the results support
substantial 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).