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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.

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

• Sample Size (Clinical Study/Test Set): 28 subjects.
• Data Provenance: Single study site in the United States. The study design was a single-arm randomized crossover study, where subjects served as their own control, comparing the self-fitted Vibe SF (investigational device) to the Silk 1X HCP fit (comparator device) in real-life conditions. This indicates a prospective study.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth for the "HCP fit" arm was established by a hearing care professional (HCP). The document doesn't specify the exact number of HCPs involved in fitting the devices for the comparison, nor their specific qualifications (e.g., years of experience). However, it implies that the HCP fit leveraged "recognized prescriptive targets from the NAL-NL2" (National Acoustic Laboratories' Nonlinear Version 2).

3. Adjudication Method for the Test Set

• The study was designed as a single-arm randomized crossover study with patients serving as their own control. This means each participant experienced both the self-fit and HCP-fit conditions. Therefore, no external adjudication of results was explicitly described in the context of expert review of the APHAB scores; the "ground truth" for the HCP arm was the HCP's fitting based on NAL-NL2.

4. 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

• No, an MRMC comparative effectiveness study was not done in the traditional sense of evaluating human reader performance with and without AI assistance for interpretation. This study focused on comparing two different fitting strategies (self-fit vs. HCP-fit) for a self-fitting hearing aid, not on improving human clinician interpretation of diagnostic images or data with AI. The device itself (Vibe SF) is the "AI" component, providing the self-fitting algorithm.

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

• The study design inherently includes the user as part of the "self-fitting" algorithm's performance, as the user adjusts the device based on the software tools. While the self-fitting algorithm provided by the EasyFit web application is a core component, its performance is measured through the user's interaction and the resulting perceived benefit. Therefore, a pure "algorithm only" standalone performance without any user interaction/input was not explicitly described beyond the fundamental function of the self-fitting software guiding the user. The "Vibe SF strategy" itself is the "algorithm only" aspect, as it is the automated fitting process, but its effectiveness is measured via user outcomes.

6. The Type of Ground Truth Used

• The primary ground truth for the effectiveness endpoint was patient-reported benefit as measured by the APHAB questionnaire.
• For the comparative arm, the "truth" was the fitting performed by a hearing care professional (HCP) adhering to established prescriptive targets (NAL-NL2). This is a form of expert consensus/best practice.
• Secondary endpoints like QuickSIN scores and Real Ear Measurements provided objective measures to support the patient-reported outcomes, comparing the actual performance of the hearing aid with an objective standard (NAL-NL2 targets) for gain.

7. The Sample Size for the Training Set

• The document does not explicitly state the sample size of the training set for the Vibe SF's self-fitting algorithm. The provided information focuses on the clinical validation study (test set) for the device. The proprietary nature of the fitting algorithm suggests that the "training" would have occurred during its development, potentially using a different dataset or real-world data, which is not detailed here.

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

• Similar to the training set size, the document does not detail how the ground truth for the training set was established for the self-fitting algorithm. It only mentions that the self-fitting strategy uses a "proprietary fitting algorithm" that integrates user input with a self-fitting strategy. This implies that the algorithm's development (and thus its "training") would have involved a methodology to define optimal hearing aid settings, likely based on audiological science, hearing models, and potentially existing patient data, but these specifics are not provided.

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