(109 days)
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
| 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.
§ 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.