(109 days)
Not Found
No
The description focuses on a self-fitting strategy based on user input and pre-defined "clusters" of settings, without mentioning AI or ML algorithms for learning or adaptation.
Yes
The device is described as "intended to compensate for impaired hearing," which indicates a therapeutic purpose.
No
Explanation: The device is described as a "Self-Fitting Hearing Aid" intended to amplify sound for individuals with perceived mild to moderate hearing impairment. Its purpose is to compensate for impaired hearing and allow users to customize their hearing aid settings, not to diagnose a medical condition. While it performs an "acoustic profiling test," this test is used to guide the self-fitting process, not to provide a medical diagnosis of hearing loss.
No
The device description explicitly states that the SF Gen 2 includes hardware components such as earpieces, housing, circuit board, battery, and electroacoustic components, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment." This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The description focuses on the hardware and software components that facilitate sound amplification and user-driven fitting. There is no mention of analyzing biological samples or providing diagnostic information about a disease or condition.
- Lack of Diagnostic Function: The device helps users compensate for hearing loss, but it does not diagnose the cause or nature of the hearing impairment. The "acoustic profiling test" is part of the self-fitting process, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This hearing aid does not perform such functions.
N/A
Intended Use / 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 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.
Product codes
QUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Direct-to-consumer sale and use without the assistance of a hearing care professional. Home healthcare environment 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
| 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 69:2017 ANSI C63.27:2021 | Wireless Functionality and Coexistence | Pass |
| ANSI/ASA S3.22:2014 ANSI/CTA 2051:2017 21 CFR § 800.30 | Electroacoustic Performance | Pass |
| IEC 62304 A1:2016 | Software Verification / Validation | Pass |
| IEC 62133-2:2017 UL 1642:2014 | Battery Safety | Pass |
| ISO 14971:2019 AAMI TIR57:2016 | Risk Assessment | Pass |
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.
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
Not Found
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
Image /page/0/Picture/0 description: The image 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"
1
(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
2
Indications for Use
Submission Number (if known)
Device Name
WSA Self-Fitting Hearing Aid Gen 2
Indications for Use (Describe)
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.
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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3
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 The | |
| Counter) | ||
| Device Classification: | Class II |
3. Predicate Device:
WSAUD A/S's Vibe SF Self-Fitting Hearing Aid (K220403)
4. 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
4
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.
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.
5
- 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 Hearing
Aid Gen 2 | Predicate Device
Vibe SF Self-Fitting
Hearing Aid (K220403) | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Product Code | QUH | QDD | Supports substantial
equivalence ("SE") given
change in hearing aid
regulations since
clearance of predicate. |
| Classification
Regulation | 21 CFR 874.3325 | 21 CFR 874.3325 | Same |
| 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 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. | The Vibe SF self-fitting
hearing aid is intended to
amplify sound for
individuals 18 years of age
or older with perceived mild
to moderate hearing
impairment. It is adjusted by
the user to meet the user's
hearing needs through
software tools. The device
is intended for direct-to-
consumer sale and use
without the assistance of a
hearing care professional.
The EasyFit self-fitting
web application is
intended to support self-
fitting and fine-tuning of
the Vibe SF hearing aid. | Same |
| Power Source | Built-in Lithium-Ion
rechargeable battery | Disposable zinc-air battery | Supports SE. Testing
shows rechargeable
battery is safe. |
| Labelling | Includes applicable
requirements of 21 CFR
800.30. | Includes applicable
requirements of 21 CFR
801.420 and 801.421. | Supports SE given
change in hearing aid
regulations since
clearance of predicate. |
| Acoustic
Characteristics | Max OSPL 90: 114 dB
SPL
Fitted OSPL 90: 99 dB
SPL
Full-on gain: 44 dB | Max OSPL 90: 114 dB
SPL
Fitted OSPL 90: 103 dB
SPL
Full-on gain: 45 dB | Supports SE. Both are
adequate for fitting
moderate hearing loss
(55 dB HL) as prescribed
by NAL-NL2. |
| Frequency
Range | 250 – 8000 Hz or 100-
9100 Hz (depending on
measurement method) | 100 – 8600 Hz | Supports SE. Both are
adequate for fitting
moderate hearing loss as
prescribed by NAL-NL2. |
| Input Noise | 23 dBA | 20 dBA | Supports SE. Both
comply to the required |
| Property | Subject Device:
WSA Self-Fitting Hearing
Aid Gen 2 | Predicate Device
Vibe SF Self-Fitting
Hearing Aid (K220403) | Comparison |
| | | | self-generated noise limit
of 32 dB A per 21 CFR
800.30(e)(2). |
| Clusters | 6 | 4 | Does not affect SE.
Change does not
significantly affect self-
fitting process. |
| Chip Platform: | Version D12+ with a
modified analog front-end
chip, digital signal
processing chip and
embedded software | Version D11 | Does not affect SE.
Testing confirms the
differences do not affect
self-fitting functionality. |
| Self-Fitting App | Web application running
on a browser integrated
into the mobile app | Web application running
on standard web browser
on mobile phone | Supports SE. Different
way of accessing the app
does not change
functionality. |
Comparison of Subject and Predicate Devices
6
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 69:2017 | ||
| ANSI C63.27:2021 | Wireless Functionality and Coexistence | Pass |
| ANSI/ASA S3.22:2014 | ||
| ANSI/CTA 2051:2017 | ||
| 21 CFR § 800.30 | Electroacoustic Performance | Pass |
| IEC 62304 A1:2016 | Software Verification / Validation | Pass |
| IEC 62133-2:2017 | ||
| UL 1642:2014 | Battery Safety | Pass |
| ISO 14971:2019 | ||
| AAMI TIR57:2016 | Risk Assessment | Pass |
7
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.