The WSA Self-Fitting Hearing Aid Gen 2 is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs through software tools. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.

Device Description

The WSA Self-Fitting Hearing Aid Gen 2 ("SF Gen 2") is a self-fitting air conduction hearing aid 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.

The SF Gen 2 hardware includes: Earpieces (sleeves), housing, circuit board including a chip set running embedded software, antenna for near-field magnetic inductive wireless connection for data exchange between the left and right hearing aids, rechargeable battery, and electroacoustic components. The instant fit in-the ear (ITE) style of the hearing aids uses sleeves in 4 different sizes to couple with the ear canal. The sleeves are available in vented and closed styles. The hearing aids are powered by built-in rechargeable Lithium-lon batteries. The device includes embedded software that communicates with the self-fitting software app.

The SF Gen 2 self-fitting system consists of: (a) a wireless hearing aid with a self-fitting feature, and (b) a software application to support hearing aid self-fitting and fine tuning. The subject device is fitted for bilateral use. Left and right hearing aids can communicate with each other over a magnetic inductive wireless link, and the hearing aids communicate with the self-fitting web application (the "self-fitting app") using acoustic technology.

The SF Gen 2 self-fitting app is run on an Internet browser that is integrated into a software app that is downloaded onto and accessed through the user's mobile device. The self-fitting strategy begins with an acoustic profiling test that the user performs while wearing the hearing aids. Based on the user's hearing profile, a "cluster" of initial settings is applied to each hearing aid, and users are then guided through fine-tuning of these settings to self-fit the hearing aids for their particular needs and comfort. The mobile app also allows the user to adjust audiological gain parameters and preferred settings on the hearing aid, and functions as a remote control for adjusting hearing aid volume during daily use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "WSA Self-Fitting Hearing Aid Gen 2" and claims substantial equivalence to a predicate device, the "Vibe SF Self-Fitting Hearing Aid (K220403)".

While it mentions performance testing for various engineering properties, it explicitly states that "no new clinical performance testing was required." This means there is no detailed study described that establishes a specific acceptance criterion (e.g., in terms of hearing improvement or speech understanding) and then proves the device meets it through a clinical trial. Instead, the argument for safety and effectiveness is based on the device's substantial equivalence to a previously cleared predicate and non-clinical performance testing of its components.

Therefore, the requested information elements related to clinical study design (sample size, ground truth, expert opinions, MRMC, standalone performance) cannot be fully answered as these types of studies were not conducted or described for this specific submission as per the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Implied by Standards/Regulations)	Reported Device Performance (SF Gen 2)
Electrical Safety & EMC	Compliance with IEC 60601-1 Ed. 3.2:2020, IEC 60601-1-2 Ed. 4.1:2020, IEC 60601-1-11 Ed. 2.1:2020, IEC 60601-2-66 Ed. 3.0:2019	Pass
Wireless Functionality & Coexistence	Compliance with AAMI TIR 69:2017, ANSI C63.27:2021	Pass
Electroacoustic Performance	Compliance with ANSI/ASA S3.22:2014, ANSI/CTA 2051:2017, 21 CFR § 800.30	Pass
Max OSPL 90	Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 114 dB SPL)	114 dB SPL
Fitted OSPL 90	Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 103 dB SPL)	99 dB SPL
Full-on gain	Adequate for fitting moderate hearing loss (55 dB HL) as prescribed by NAL-NL2. (Predicate: 45 dB)	44 dB
Frequency Range	Adequate for fitting moderate hearing loss as prescribed by NAL-NL2. (Predicate: 100 – 8600 Hz)	250 – 8000 Hz or 100-9100 Hz
Input Noise (Self-generated)	Comply to the required limit of 32 dB A per 21 CFR 800.30(e)(2). (Predicate: 20 dBA)	23 dBA
Software Verification / Validation	Compliance with IEC 62304 A1:2016	Pass
Battery Safety	Compliance with IEC 62133-2:2017, UL 1642:2014	Pass
Risk Assessment	Compliance with ISO 14971:2019, AAMI TIR57:2016	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set or patient data used for evaluation of the device's hearing performance. The "Performance Testing" section refers to non-clinical (engineering) tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set with human-established ground truth for hearing performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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

Not applicable. The device is a self-fitting hearing aid, not an AI diagnostic tool primarily evaluated with human readers. The submission explicitly states "no new clinical performance testing was required."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes non-clinical technical testing (e.g., electroacoustic performance, software validation) of the device's components and overall system. While these tests evaluate the "algorithm" or device's standalone performance in specific technical domains, it does not refer to "standalone performance" in the context of a clinical outcome that would typically be compared to human performance (e.g., a standalone AI diagnostic algorithm).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests, the "ground truth" or reference is typically the specified international standards and regulations (e.g., IEC, ANSI, CFR requirements). For example, electroacoustic performance is compared against the limits defined in ANSI/ASA S3.22:2014.

8. The sample size for the training set

Not applicable. The document does not describe the development or training of a machine learning model beyond the general mention of a "self-fitting strategy" which "integrates user input with a self-fitting strategy." It does not specify a separate training set for a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning algorithm is described.

Summary

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Image /page/0/Picture/0 description: The image contains 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 includes the text "U.S. Food & Drug Administration" in blue.

February 9, 2024

Wsaud A/s % John Smith Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street. NW Washington, District of Columbia 20004

Re: K233464

Trade/Device Name: WSA Self-Fitting Hearing Aid Gen 2 Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: October 23, 2023 Received: January 11, 2024

Dear John Smith:

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.

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"

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(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 (QS) 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 OS 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.

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.

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.

Shuchen Peng -S

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 Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233464

Device Name

WSA Self-Fitting Hearing Aid Gen 2

Indications for Use (Describe)

The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K233464

1. Submitter

WSAUD A/S Nymøllevej 6 DK-3540 Lynge Denmark Phone: 1561-785-9321 Contact Person: La-Shaunda Joseph, US Regulatory Affairs Manger Lashaunda.joseph@wsa.com

Date Prepared: February 9, 2024

2. Subject Device

	Device Proprietary Name:	WSA Self-Fitting Hearing Aid Gen 2
	Common or Usual name:	Hearing Aid
	Classification Name:	Self-Fitting Air-Conduction Hearing Aid
	Regulatory Number:	21 C.F.R. § 874.3325
	Product Code:	QUH (Self-Fitting Air-Conduction Hearing Aid, Over TheCounter)
	Device Classification:	Class II

3. Predicate Device:

WSAUD A/S's Vibe SF Self-Fitting Hearing Aid (K220403)

4. Device Description

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each other over a magnetic inductive wireless link, and the hearing aids communicate with the self-fitting web application (the "self-fitting app") using acoustic technology.

5. Indications for Use

The WSA Self-Fitting Hearing Aid Gen 2 is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs through software tools. The device is intended for directto-consumer sale and use without the assistance of a hearing care professional.

The SF-App is intended to support self-fitting and fine-tuning of the hearing aid.

6. Comparison of Technological Characteristics

Both the subject and predicate devices are self-fitting hearing aids indicated for individuals 18 years of age 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. Both devices are instant fit in-the ear (ITE) hearing aids designed for all-day wear. At a high level, the subject and predicate devices are based on the following same technological elements:

o Self-fit hearing aid.
Home healthcare environment use. o
Software to support self-fitting and fine-tuning of the hearing aid. ●
Software platform compatibility (iOS, Android).

Both devices use the same communication technology, including near-field magnetic inductive wireless link for data exchange between the left and right hearing aid, and acoustic technology for communication between the hearing aids and the self-fitting app. Additionally, both employ the same self-fitting strategy, which is implemented using a web-based application (the "self-fitting app").

The main design differences between the subject and predicate devices are:

o The self-fitting app is accessed through a web browser embedded in a dedicated mobile app for the hearing aid, rather than through a standalone web browser.
0 Change in the number of clusters that can be applied as a starting point for the user's own fine-tuning, from 4 clusters in the predicate to 6 in the subject device.
Subject device is powered by rechargeable Lithium-lon batteries, whereas the predicate device used disposable Zinc-Air hearing aid batteries.
. Subject device uses an updated chip set and updated embedded software.

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Subject device conforms to new labeling requirements for OTC hearing aids under . 21 CFR 800.30.
A table comparing the key features of the SF Gen 2 to the predicate is provided below.

Property	Subject Device:WSA Self-Fitting HearingAid Gen 2	Predicate DeviceVibe SF Self-FittingHearing Aid (K220403)	Comparison
Product Code	QUH	QDD	Supports substantialequivalence ("SE") givenchange in hearing aidregulations sinceclearance of predicate.
ClassificationRegulation	21 CFR 874.3325	21 CFR 874.3325	Same
Indications foruse	The WSA Self-FittingHearing Aid Gen 2 isintended to amplify soundfor individuals 18 years ofage or older with perceivedmild to moderate hearingimpairment. It is adjusted bythe user to meet the user'shearing needs throughsoftware tools. The deviceis intended for Direct-to-consumer sale and usewithout the assistance of ahearing care professional.The SF-App is intended tosupport self-fitting andfine-tuning of the hearingaid.	The Vibe SF self-fittinghearing aid is intended toamplify sound forindividuals 18 years of ageor older with perceived mildto moderate hearingimpairment. It is adjusted bythe user to meet the user'shearing needs throughsoftware tools. The deviceis intended for direct-to-consumer sale and usewithout the assistance of ahearing care professional.The EasyFit self-fittingweb application isintended to support self-fitting and fine-tuning ofthe Vibe SF hearing aid.	Same
Power Source	Built-in Lithium-Ionrechargeable battery	Disposable zinc-air battery	Supports SE. Testingshows rechargeablebattery is safe.
Labelling	Includes applicablerequirements of 21 CFR800.30.	Includes applicablerequirements of 21 CFR801.420 and 801.421.	Supports SE givenchange in hearing aidregulations sinceclearance of predicate.
AcousticCharacteristics	Max OSPL 90: 114 dBSPLFitted OSPL 90: 99 dBSPLFull-on gain: 44 dB	Max OSPL 90: 114 dBSPLFitted OSPL 90: 103 dBSPLFull-on gain: 45 dB	Supports SE. Both areadequate for fittingmoderate hearing loss(55 dB HL) as prescribedby NAL-NL2.
FrequencyRange	250 – 8000 Hz or 100-9100 Hz (depending onmeasurement method)	100 – 8600 Hz	Supports SE. Both areadequate for fittingmoderate hearing loss asprescribed by NAL-NL2.
Input Noise	23 dBA	20 dBA	Supports SE. Bothcomply to the required
Property	Subject Device:WSA Self-Fitting HearingAid Gen 2	Predicate DeviceVibe SF Self-FittingHearing Aid (K220403)	Comparison
			self-generated noise limitof 32 dB A per 21 CFR800.30(e)(2).
Clusters	6	4	Does not affect SE.Change does notsignificantly affect self-fitting process.
Chip Platform:	Version D12+ with amodified analog front-endchip, digital signalprocessing chip andembedded software	Version D11	Does not affect SE.Testing confirms thedifferences do not affectself-fitting functionality.
Self-Fitting App	Web application runningon a browser integratedinto the mobile app	Web application runningon standard web browseron mobile phone	Supports SE. Differentway of accessing the appdoes not changefunctionality.

Comparison of Subject and Predicate Devices

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7. Performance Testing

Performance testing, summarized below, was conducted to demonstrate that the SF Gen 2 is as safe and effective as the predicate.

WSAUD conducted a series of non-clinical tests on the SF Gen 2 to assess electrical safety, EMC, wireless coexistence, electroacoustic performance, biocompatibility, and software verification/validation. Device and application firmware and software have been validated per the same standards used to validate the predicate's device and application firmware and software. The results are summarized in the table below:

Performance Testing

Property	Test	Result
IEC 60601-1 Ed. 3.2:2020	EMC and Electrical Safety	Pass
IEC 60601-1-2 Ed. 4.1:2020
IEC 60601-1-11 Ed. 2.1:2020
IEC 60601-2-66 Ed. 3.0:2019
AAMI TIR 69:2017ANSI C63.27:2021	Wireless Functionality and Coexistence	Pass
ANSI/ASA S3.22:2014ANSI/CTA 2051:201721 CFR § 800.30	Electroacoustic Performance	Pass
IEC 62304 A1:2016	Software Verification / Validation	Pass
IEC 62133-2:2017UL 1642:2014	Battery Safety	Pass
ISO 14971:2019AAMI TIR57:2016	Risk Assessment	Pass

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In all instances, the SF Gen 2 functioned as intended and results observed were as expected.

The self-fitting strategy is unchanged in the SF Gen 2 compared to the Vibe SF. Although the SF Gen 2 has a minor modification to the "clusters" of hearing aid settings that are applied after the user's hearing profile test, these clusters are not intended to provide final settings for users, but rather to provide a starting point for the user's own fine-tuning. Therefore, the modification to the clusters does not constitute a change in the self-fitting strategy, and no new clinical performance testing was required.

8. Conclusion

The WSA Self-Fitting Hearing Aid Gen 2 is as safe and effective as the predicate Vibe SF Self-Fitting Hearing Aid (K220403). The WSA Self-Fitting Hearing Aid Gen 2 has the same intended use indications for use, and similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between the subject and predicate devices raise no new issues of safety or effectiveness. Therefore, the SF Gen 2 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.