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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 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.

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

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.

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The Vibe SF seff-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'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.

The Vibe SF Self-Fitting Hearing Aid ("Vibe SF") 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 Vibe SF hearing aid is based on WSAUD's wireless hearing aid series Signia Silk 1X (regulated under 21 C.F.R. § 874.3305). However, unlike standard wireless air-conduction hearing aids, the Vibe SF is intended to be sold directly to the end-user without involvement of a hearing care professional. Briefly, the self-fitting hearing aid system consists of two components:

• a) A wireless hearing aid with a self-fitting feature (Vibe SF); and
• b) A mobile web application (EasyFit) to support the self-fitting and fine-tuning of the hearing aid.

The Vibe SF wireless hearing aid hardware includes: Ear pieces (click sleeves), housing, circuit board, battery, chip, and electroacoustic components. The subject device is fitted for bilateral use with a left and right device. Left and right hearing aids are able to communicate with each other over a magnetic inductive wireless link. The instant fit in-the-ear (ITE) style of the Vibe SF hearing aid uses Click Sleeves in 4 different sizes to couple with the ear canal. The hearing aids are marked with 'R' for right and 'L' for left, and are powered by standard (non-rechargeable) Zinc-Air batteries (size 10A). The Vibe SF hearing aid includes software that communicates with the EasyFit app to provide self-fitting functionality.

The Vibe SF is fitted by the user through the EasyFit self-fitting web application, which is run on an Internet browser on the user's mobile device (smartphone or tablet with iOS or Android operating system). The EasyFit self-fitting web application guides the user through the selffitting procedure and also allows the user to set audiological gain parameters and preferred settings on the Vibe SF Hearing Aid. In addition, a software application (app for iOS and Android) called Vibe app is available as remote control for adjusting volume during daily use.

Here's a breakdown of the acceptance criteria and study details for the Vibe SF Self-Fitting Hearing Aid, based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary objective of the clinical study was to demonstrate non-inferiority of the Vibe SF self-fitting strategy compared to an audiologist-fit (HCP fit) strategy regarding perceived hearing aid benefit. This was measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) subscales for ease of communication (EC), background noise (BN), and reverberant room (RV).

The acceptance criterion for effectiveness was simultaneous non-inferiority on all three APHAB subscales.

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